Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT00748072 |
Date of registration:
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05/09/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy
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Scientific title:
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1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial |
Date of first enrolment:
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August 2008 |
Target sample size:
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162 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00748072 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Carlo Manno, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Bari |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Kidney Failure
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Intervention(s)
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Drug: DDAVP
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Drug: saline solution
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Primary Outcome(s)
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The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.
[Time Frame: Immediately post-biopsy and 24 hours post-biopsy.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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