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

This study has been completed.
Information provided by (Responsible Party):
Carlo Manno, University of Bari Identifier:
First received: September 5, 2008
Last updated: December 30, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Kidney Failure Drug: DDAVP Drug: saline solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Carlo Manno, University of Bari:

Primary Outcome Measures:
  • The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. [ Time Frame: Immediately post-biopsy and 24 hours post-biopsy. ]

Enrollment: 162
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline solution
patients treated with 1 ml of s.c. saline solution
Drug: saline solution
saline solution 1 ml subcutaneous
Other Name: placebo
Experimental: DDAVP
treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
0.3 mcg/kg subcutaneous
Other Name: vasopressin

Detailed Description:

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.


Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00748072

Center and Atelier for Epidemiological Studies, University of Bari
Bari, Italy, 70124
Sponsors and Collaborators
University of Bari
Principal Investigator: Carlo Manno, MD University of Bari
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carlo Manno, Assistant Professor, Chair of Nephrology, Unit of Nephrology, University of Bari, Bari, Italy, University of Bari Identifier: NCT00748072     History of Changes
Other Study ID Numbers: DDAVP 01
Study First Received: September 5, 2008
Results First Received: December 30, 2014
Last Updated: December 30, 2014

Keywords provided by Carlo Manno, University of Bari:

Additional relevant MeSH terms:
Diabetes Insipidus
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Pharmaceutical Solutions
Arginine Vasopressin
Deamino Arginine Vasopressin
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs processed this record on September 18, 2017