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

NCT ID: NCT00748072

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Kidney Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Saline solution

patients treated with 1 ml of s.c. saline solution

Group Type: PLACEBO_COMPARATOR

saline solution

Intervention Type: DRUG

saline solution 1 ml subcutaneous

DDAVP

treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy

Group Type: EXPERIMENTAL

DDAVP

Intervention Type: DRUG

0.3 mcg/kg subcutaneous

Interventions

DDAVP

0.3 mcg/kg subcutaneous

Intervention Type: DRUG

saline solution

saline solution 1 ml subcutaneous

Intervention Type: DRUG

Other Intervention Names

vasopressin; placebo

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bari

OTHER

Sponsor Role: lead

Responsible Party

Carlo Manno

Assistant Professor, Chair of Nephrology, Unit of Nephrology, University of Bari, Bari, Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Manno, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

Center and Atelier for Epidemiological Studies, University of Bari

Bari, Bari, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 21354681 (View on PubMed)

Other Identifiers

DDAVP 01

Identifier Type: -

Identifier Source: org_study_id