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1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy

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ClinicalTrials.gov Identifier: NCT00748072
Recruitment Status : Completed
First Posted : September 8, 2008
Results First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Carlo Manno, University of Bari

September 5, 2008
September 8, 2008
December 30, 2014
January 13, 2015
January 13, 2015
August 2008
August 2009   (Final data collection date for primary outcome measure)
The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. [ Time Frame: Immediately post-biopsy and 24 hours post-biopsy. ]
presence/absence of haematoma [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT00748072 on ClinicalTrials.gov Archive Site
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1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy
1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial
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.

Renal biopsy is an essential procedure in the diagnosis of primary and secondary renal diseases. The technique has significantly improved over the past two decades because of the introduction of ultrasonography and automated-gun biopsy devices; however an accurate clinical, chemistry and renal ultrasound evaluation before and 24-hours post renal biopsy is necessary, because bleeding complications still occur in about 1/3 of our procedures, with major complications occurring in only 1.2% of patients. Of the data routinely collected for potential predictors of post-biopsy bleeding complications, only gender, age, and baseline partial thromboplastin time show a significant predictive value. The other variables investigated do not have any predictive value (Manno C et al, Kidney Int 2004). The majority of published studies, retrospective and non-randomized, on this topic have focused on the comparative performance of different renal biopsy techniques and types of needles, but no study has shown potential predictors of post-biopsy bleeding complications. On the other hand, the available studies have not shown any specific test to select patients with major risk of post-biopsy bleeding.

The aim of this study is to evaluate the effect of pre-biopsy treatment with DDAVP or desmopressin on the incidence of post-biopsy bleeding complications.

DDAVP is a synthetic derivative of the anti-diuretic hormone vasopressin; therefore, the administration of DDAVP is often accompanied by water retention, a drop in blood pressure and a secondary increase in heart rate. The haemostatic effect of DDAVP is related to an increase of vWF-factor VIII levels. DDAVP is the treatment of choice for most patients with von Willebrand (type I) disease and haemophilia A; moreover, the compound has been shown to be useful in a variety of inherited and acquired hemorrhagic conditions, including some congenital platelet function defects, chronic liver disease, uremia, and haemostatic defects induced by the therapeutic use of anti-thrombotic drugs such as aspirin and ticlopidine. Finally, DDAVP has been used as a haemostatic agent in patients undergoing surgery at major risk of bleeding. Disadvantages of DDAVP include reported rare thrombotic events.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Kidney Failure
  • Drug: DDAVP
    0.3 mcg/kg subcutaneous
    Other Name: vasopressin
  • Drug: saline solution
    saline solution 1 ml subcutaneous
    Other Name: placebo
  • Placebo Comparator: Saline solution
    patients treated with 1 ml of s.c. saline solution
    Intervention: Drug: saline solution
  • Experimental: DDAVP
    treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
    Intervention: Drug: DDAVP
Manno C, Bonifati C, Torres DD, Campobasso N, Schena FP. Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial. Am J Kidney Dis. 2011 Jun;57(6):850-5. doi: 10.1053/j.ajkd.2010.12.019. Epub 2011 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
124
December 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 80 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00748072
DDAVP 01
No
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Carlo Manno, University of Bari
University of Bari
Not Provided
Principal Investigator: Carlo Manno, MD University of Bari
University of Bari
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP