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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00748072
Recruitment Status : Completed
First Posted : September 8, 2008
Results First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Information provided by (Responsible Party):
Carlo Manno, University of Bari

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Failure Drug: DDAVP Drug: saline solution Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
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
Study Start Date : August 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00748072

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Center and Atelier for Epidemiological Studies, University of Bari
Bari, Italy, 70124
Sponsors and Collaborators
University of Bari
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Principal Investigator: Carlo Manno, MD University of Bari
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Carlo Manno, Assistant Professor, Chair of Nephrology, Unit of Nephrology, University of Bari, Bari, Italy, University of Bari Identifier: NCT00748072    
Other Study ID Numbers: DDAVP 01
First Posted: September 8, 2008    Key Record Dates
Results First Posted: January 13, 2015
Last Update Posted: January 13, 2015
Last Verified: December 2014
Keywords provided by Carlo Manno, University of Bari:
Additional relevant MeSH terms:
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Renal Insufficiency
Diabetes Insipidus
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs