Study · Randomized controlled trial · n = 20 · 2001

16 results

Infusion of methylene blue in human septic shock: a pilot, randomized, controlled study.

Kirov MY, Evgenov OV, Evgenov NV, Egorina EM, Sovershaev MA, Sveinbjørnsson B, Nedashkovsky EV, Bjertnaes LJ

Critical care medicine1 Oct 2001Cited by 173 (Europe PMC)

PMID11588440DOI10.1097/00003246-200110000-00002PepBankPUB-11588440

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study16

16 results from studies that gave the peptide. 16 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with septic shock, methylene blue prevented the stroke volume index from falling.
In plain wordsIn patients with septic shock, methylene blue prevented the stroke volume index from falling.
Peptide
Methylene blue
Outcome
IncreaseStroke volume index
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Heart function · Cardiovascular
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Infusion of MB prevented the stroke volume and the left-ventricular stroke work indexes from falling and increased mean arterial pressure.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844001
02HumanRandomized controlled trialEfficacy outcome
In patients with septic shock, methylene blue prevented the left-ventricular stroke work index from falling.
In plain wordsIn patients with septic shock, methylene blue prevented the heart's stroke work index from falling.
Peptide
Methylene blue
Outcome
IncreaseLeft-ventricular stroke work index
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Heart function · Cardiovascular
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Infusion of MB prevented the stroke volume and the left-ventricular stroke work indexes from falling and increased mean arterial pressure.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844002
03HumanRandomized controlled trialEfficacy outcome
In patients with septic shock, methylene blue increased mean arterial pressure.
In plain wordsIn patients with septic shock, methylene blue increased average arterial pressure.
Peptide
Methylene blue
Outcome
IncreaseMean arterial pressure
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Blood pressure · Cardiovascular
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Infusion of MB prevented the stroke volume and the left-ventricular stroke work indexes from falling and increased mean arterial pressure.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844003
04HumanRandomized controlled trialEfficacy outcome
In patients with septic shock, methylene blue reduced norepinephrine requirements by as much as 87% versus controls.
In plain wordsIn patients with septic shock, methylene blue reduced norepinephrine requirements by as much as 87% compared with controls.
Peptide
Methylene blue
Outcome
DecreaseNorepinephrine requirement
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Intensive care and hospital outcomes · Cardiovascular
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Measurements
Reduction in norepinephrine requirement
≤ 87%
methylene blue versus control group (reported as 'as much as')
Source sentences
Summary
Compared with the control group, MB reduced the requirement for norepinephrine, epinephrine, and dopamine by as much as 87%, 81%, and 40%, respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844004
05HumanRandomized controlled trialEfficacy outcome
In patients with septic shock, methylene blue reduced epinephrine requirements by as much as 81% versus controls.
In plain wordsIn patients with septic shock, methylene blue reduced epinephrine requirements by as much as 81% compared with controls.
Peptide
Methylene blue
Outcome
DecreaseEpinephrine requirement
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Intensive care and hospital outcomes · Cardiovascular
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Measurements
Reduction in epinephrine requirement
≤ 81%
methylene blue versus control group (reported as 'as much as')
Source sentences
Summary
Compared with the control group, MB reduced the requirement for norepinephrine, epinephrine, and dopamine by as much as 87%, 81%, and 40%, respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844005
06HumanRandomized controlled trialEfficacy outcome
In patients with septic shock, methylene blue reduced dopamine requirements by as much as 40% versus controls.
In plain wordsIn patients with septic shock, methylene blue reduced dopamine requirements by as much as 40% compared with controls.
Peptide
Methylene blue
Outcome
DecreaseDopamine requirement
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Intensive care and hospital outcomes · Cardiovascular
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Measurements
Reduction in dopamine requirement
≤ 40%
methylene blue versus control group (reported as 'as much as')
Source sentences
Summary
Compared with the control group, MB reduced the requirement for norepinephrine, epinephrine, and dopamine by as much as 87%, 81%, and 40%, respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844006
07HumanRandomized controlled trialEfficacy outcome
In patients with septic shock, oxygen delivery remained unchanged with methylene blue but decreased in controls.
In plain wordsIn patients with septic shock, oxygen delivery stayed unchanged with methylene blue but fell in controls.
Peptide
Methylene blue
Outcome
MixedOxygen delivery
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Heart function · Cardiovascular
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Oxygen delivery remained unchanged in the MB group and decreased in the control group.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844007
08HumanRandomized controlled trialEfficacy outcome
In patients with septic shock, methylene blue reduced body temperature.
In plain wordsIn patients with septic shock, methylene blue reduced body temperature.
Peptide
Methylene blue
Outcome
DecreaseBody temperature
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Body temperature · Whole body
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
MB also reduced the body temperature and the plasma concentration of nitrates/nitrites.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844008
09HumanRandomized controlled trialMechanism
In patients with septic shock, methylene blue reduced plasma nitrate/nitrite concentrations.
In plain wordsIn patients with septic shock, methylene blue reduced blood nitrate/nitrite levels.
Peptide
Methylene blue
Outcome
DecreasePlasma nitrates/nitrites
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Receptor activity and mechanism · Cardiovascular
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
MB also reduced the body temperature and the plasma concentration of nitrates/nitrites.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844009
10HumanRandomized controlled trialSafety outcome
In patients with septic shock, methylene blue did not significantly affect leukocytes.
In plain wordsIn patients with septic shock, methylene blue did not significantly affect white blood cells.
Peptide
Methylene blue
Outcome
No significant changeLeukocytes
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Immune response · Immune and inflammation
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Leukocytes and organ function variables such as bilirubin, alanine aminotransferase, urea, and creatinine were not significantly affected.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844010
11HumanRandomized controlled trialSafety outcome
In patients with septic shock, methylene blue did not significantly affect bilirubin.
In plain wordsIn patients with septic shock, methylene blue did not significantly affect bilirubin.
Peptide
Methylene blue
Outcome
No significant changeBilirubin
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Liver fat and liver function · Liver
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Leukocytes and organ function variables such as bilirubin, alanine aminotransferase, urea, and creatinine were not significantly affected.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844011
12HumanRandomized controlled trialSafety outcome
In patients with septic shock, methylene blue did not significantly affect alanine aminotransferase.
In plain wordsIn patients with septic shock, methylene blue did not significantly affect the liver enzyme alanine aminotransferase.
Peptide
Methylene blue
Outcome
No significant changeAlanine aminotransferase
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Liver fat and liver function · Liver
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Leukocytes and organ function variables such as bilirubin, alanine aminotransferase, urea, and creatinine were not significantly affected.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844012
13HumanRandomized controlled trialSafety outcome
In patients with septic shock, methylene blue did not significantly affect urea.
In plain wordsIn patients with septic shock, methylene blue did not significantly affect urea.
Peptide
Methylene blue
Outcome
No significant changeUrea
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Kidney function · Kidney and urinary
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Leukocytes and organ function variables such as bilirubin, alanine aminotransferase, urea, and creatinine were not significantly affected.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844013
14HumanRandomized controlled trialSafety outcome
In patients with septic shock, methylene blue did not significantly affect creatinine.
In plain wordsIn patients with septic shock, methylene blue did not significantly affect creatinine.
Peptide
Methylene blue
Outcome
No significant changeCreatinine
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Kidney function · Kidney and urinary
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Leukocytes and organ function variables such as bilirubin, alanine aminotransferase, urea, and creatinine were not significantly affected.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844014
15HumanRandomized controlled trialSafety outcome
In patients with septic shock, platelet counts decreased in both methylene blue and control groups.
In plain wordsIn patients with septic shock, platelet counts fell in both methylene blue and control groups.
Peptide
Methylene blue
Outcome
Direction not reportedPlatelet count
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Adverse events · Whole body
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Source sentences
Summary
Platelet count decreased in both groups.
4 context sentences(design, population, supporting numbers)
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844015
16HumanRandomized controlled trialSafety outcome
In patients with septic shock, five methylene blue recipients survived versus three controls.
In plain wordsIn patients with septic shock, five methylene blue recipients survived versus three controls.
Peptide
Methylene blue
Outcome
IncreaseSurvival at day 28
Study
n = 20
Comparator
Isotonic saline with conventional treatment
Outcome group
Mortality · Whole body
Studied dose
2 mg/kg bolus followed by 0.25, 0.5, 1, and 2 mg/kg/hr infusions · intravenousAs given in this study (human).
Measurements
Survivors
5 patients
methylene blue group
Survivors
3 patients
conventional treatment (control) group
Source sentences
Summary
Five patients treated with MB survived vs. three patients receiving conventional treatment.
5 context sentences(design, population, supporting numbers)
Summary · context
Hemodynamics and organ function variables were assessed over a 24-hr period, and the survival rate at day 28 was noted.
Summary · context
Prospective, randomized, controlled, open-label, pilot study.
Summary · context
Twenty patients with septic shock diagnosed <24 hrs before randomization.
Summary · context
Patients were randomized 1:1 to receive either MB (MB group, n = 10) or isotonic saline (control group, n = 10), adjunctive to conventional treatment.
Summary · context
MB was administered as an intravenous bolus injection (2 mg/kg), followed 2 hrs later by infusion at stepwise increasing rates of 0.25, 0.5, 1, and 2 mg/kg/hr that were maintained for 1 hr each.
Report a problemFND-1158844016

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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Trial page ClinicalTrials.govUpdated 30 Jan 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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