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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00748072
Date of registration: 05/09/2008
Prospective Registration: No
Primary sponsor: University of Bari
Public title: 1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy
Scientific title: 1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial
Date of first enrolment: August 2008
Target sample size: 162
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00748072
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
Italy
Contacts
Name:     Carlo Manno, MD
Address: 
Telephone:
Email:
Affiliation:  University of Bari
Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Kidney Failure
Intervention(s)
Drug: DDAVP
Drug: saline solution
Primary Outcome(s)
The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. [Time Frame: Immediately post-biopsy and 24 hours post-biopsy.]
Secondary Outcome(s)
Secondary ID(s)
DDAVP 01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 13/01/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00748072
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