Primary outcomeNumber· Immediately post-biopsy and 24 hours post-biopsy.
The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.
| Group | Value (participants) |
|---|---|
| Saline Solution | 25 |
| DDAVP | 11 |
Trial · Interventional
CompletedPhase 4Results postedRegistry data1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy
NCTNCT00748072 (opens ClinicalTrials.gov in a new tab)Other idDDAVP 01
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 162 participants (actual)
- Sponsor
- University of Bari · Other
- Design
- Randomized · Triple masking
- Countries
1 country
Italy
- Start
- Aug 2008
- Primary completion
- Aug 2009
- Completion
- Dec 2009
- First posted
- 8 Sept 2008 (estimated)
- Last update posted
- 13 Jan 2015 (estimated)
- Conditions
- Kidney Failure
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010
- Ph 4
1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy
NCT00748072Aug 2008 to Dec 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single centre, double blind, randomized controlled study in patients, with acute and chronic nephropathy, undergoing ultrasound-guided percutaneous renal biopsy.
Interventions
- DDAVPDrug
- saline solutionDrug
Arms2
Placebo comparator
Saline solution
patients treated with 1 ml of s.c. saline solution
Experimental
DDAVP
treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
Primary outcomes1
Outcomes the sponsor listed as primary.
The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.
Time frame · Immediately post-biopsy and 24 hours post-biopsy.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Saline Solutionpatients treated with 1 ml of s.c. saline solution | – | 0 / 82 | 0 / 82 |
| DDAVPtreated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy | – | 0 / 80 | 3 / 80 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2011
4 results
Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial.
Manno et al. 2011American journal of kidney diseases : the official journal of the National Kidney Foundationcited by 76
PMID 21354681DOI 10.1053/j.ajkd.2010.12.019PUB-21354681
Full text at the publisher4 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 16 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Males or females \> 16 and \< 80 years of age.
2. Blood pressure \< 140/90 mmHg.
3. Serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance ≥ 60 ml/min.
4. Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range.
Exclusion Criteria:
1. Biopsy of transplant kidney
2. Poorly controlled hypertension
3. Single kidney
4. Renal cancer
5. Hydro/pyonephrosis
6. Renal size significantly reduced
7. Severe obesity
8. Coagulation disorder
9. Serum creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 ml/min
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