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Study · Randomized controlled trial · n = 100 · 2024

3 results

Effect of early administration of tetracosactide on mortality and host response in critically ill patients requiring rescue surgery: a sensitivity analysis of the STOPSHOCK phase 3 randomized controlled trial.

Noera G, Bertolini A, Calzà L, Gori M, Pitino A, D'Arrigo G, Egan CG, Tripepi G

Military Medical Research19 Aug 2024

PMID39160574 (opens in a new tab)PMCIDPMC11331742 (opens in a new tab)DOI10.1186/s40779-024-00555-2 (opens in a new tab)PepBankPUB-39160574
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Summary

BackgroundUndifferentiated shock is recognized as a criticality state that is transitional in immune-mediated topology for casual risk of lethal microcirculatory dysfunction. This was a sensitivity analysis of a drug (tetracosactide; TCS10) targeting melanocortin receptors (MCRs) in a phase 3 randomized controlled trial to improve cardiovascular surgical rescue outcome by reversing mortality and hemostatic disorders.MethodsSensitivity analysis was based on a randomized, two-arm, multicenter, double-blind, controlled trial. The Naïve Bayes classifier was performed by density-based sensitivity index for principal strata as proportional hazard model of 30-day surgical risk mortality according to European System for Cardiac Operative Risk Evaluation inputs-outputs in 100 consecutive cases (from August to September 2013 from Emilia Romagna region, Italy). Patients included an agent-based TCS10 group (10 mg, single intravenous bolus before surgery; n = 56) and control group (n = 44) and the association with cytokines, lactate, and bleeding-blood transfusion episodes with the prior-risk log-odds for mortality rate in time-to-event was analyzed.ResultsThirty-day mortality was significantly improved in the TCS10 group vs. control group (0 vs. 8 deaths, P < 0.0001). Baseline levels of interleukin (IL)-6, IL-10, and lactate were associated with bleeding episodes, independent of TCS10 treatment [odds ratio (OR) = 1.90, 95% confidence interval (CI) 1.39-2.79; OR = 1.53, 95%CI 1.17-2.12; and OR = 2.92, 95%CI 1.40-6.66, respectively], while baseline level of Fms-like tyrosine kinase 3 ligand (Flt3L) was associated with lower bleeding rates in TCS10-treated patients (OR = 0.31, 95%CI 0.11-0.90, P = 0.03). For every 8 TCS10-treated patients, 1 bleeding case was avoided. Blood transfusion episodes were significantly reduced in the TCS10 group compared to the control group (OR = 0.32, 95%CI 0.14-0.73, P = 0.01). For every 4 TCS10-treated patients, 1 transfusion case was avoided.ConclusionsSensitivity index underlines the quality target product profile of TCS10 in the runway of emergency casualty care. To introduce the technology readiness level in real-life critically ill patients, further large-scale studies are required.Trial registrationEuropean Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2007-006445-41 ).
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In critically ill surgical patients, tetracosactide reduced thirty-day mortality versus control, with 0 versus 8 deaths (P < 0.0001).

    In plain wordsIn critically ill surgical patients, tetracosactide reduced mortality compared with control.

    Peptide
    Cosyntropin
    Outcome
    DecreaseThirty-day mortality
    Study

    n = 100

    Comparator
    Control
    Outcome group
    Mortality · Whole body
    Studied dose
    10 mg · intravenous bolus · single dose before surgeryAs given in this study (human).

    Measurements

    Thirty-day deaths
    0 deaths
    tetracosactide (TCS10) group
    Thirty-day deaths
    8 deaths
    control group

    Source sentences

    Summary
    Thirty-day mortality was significantly improved in the TCS10 group vs. control group (0 vs. 8 deaths, P < 0.0001).
    2 context sentences
    Summary · context
    Sensitivity analysis was based on a randomized, two-arm, multicenter, double-blind, controlled trial.
    Summary · context
    Patients included an agent-based TCS10 group (10 mg, single intravenous bolus before surgery; n = 56) and control group (n = 44) and the association with cytokines, lactate, and bleeding-blood transfusion episodes with the prior-risk log-odds for mortality rate in time-to-event was analyzed.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In critically ill surgical patients, one bleeding case was avoided for every 8 tetracosactide-treated patients versus control.

    In plain wordsIn critically ill surgical patients, tetracosactide prevented one bleeding case per 8 treated patients compared with control.

    Peptide
    Cosyntropin
    Outcome
    DecreaseBleeding prevention
    Study

    n = 100

    Comparator
    Control
    Outcome group
    Blood Loss · Cardiovascular
    Studied dose
    10 mg · intravenous bolus · single dose before surgeryAs given in this study (human).

    Measurements

    Treated patients per bleeding case avoided
    8 patients
    TCS10-treated patients

    Source sentences

    Summary
    For every 8 TCS10-treated patients, 1 bleeding case was avoided.
    2 context sentences
    Summary · context
    Sensitivity analysis was based on a randomized, two-arm, multicenter, double-blind, controlled trial.
    Summary · context
    Patients included an agent-based TCS10 group (10 mg, single intravenous bolus before surgery; n = 56) and control group (n = 44) and the association with cytokines, lactate, and bleeding-blood transfusion episodes with the prior-risk log-odds for mortality rate in time-to-event was analyzed.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In critically ill surgical patients, tetracosactide reduced transfusion episodes versus control (OR 0.32, 95%CI 0.14-0.73, P = 0.01).

    In plain wordsIn critically ill surgical patients, tetracosactide reduced blood transfusions compared with control.

    Peptide
    Cosyntropin
    Outcome
    DecreaseBlood transfusion episodes
    Study

    n = 100

    Comparator
    Control
    Outcome group
    Blood Transfusion · Cardiovascular
    Studied dose
    10 mg · intravenous bolus · single dose before surgeryAs given in this study (human).

    Measurements

    Odds ratio, blood transfusion episodes
    0.32 OR
    TCS10 vs control, P = 0.01
    95% CI of odds ratio
    0.14 to 0.73 OR
    TCS10 vs control
    Treated patients per transfusion case avoided
    4 patients
    TCS10-treated patients

    Source sentences

    Summary
    Blood transfusion episodes were significantly reduced in the TCS10 group compared to the control group (OR = 0.32, 95%CI 0.14-0.73, P = 0.01).
    3 context sentences
    Summary · context
    For every 4 TCS10-treated patients, 1 transfusion case was avoided.
    Summary · context
    Sensitivity analysis was based on a randomized, two-arm, multicenter, double-blind, controlled trial.
    Summary · context
    Patients included an agent-based TCS10 group (10 mg, single intravenous bolus before surgery; n = 56) and control group (n = 44) and the association with cytokines, lactate, and bleeding-blood transfusion episodes with the prior-risk log-odds for mortality rate in time-to-event was analyzed.

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

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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