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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline solution | Placebo Comparator | patients treated with 1 ml of s.c. saline solution |
|
| DDAVP | Experimental | treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDAVP | Drug | 0.3 mcg/kg subcutaneous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. | Immediately post-biopsy and 24 hours post-biopsy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Manno, MD | University of Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center and Atelier for Epidemiological Studies, University of Bari | Bari | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21354681 | Derived | 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. |
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The exclusion criteria were solitary kidney, kidney cancer, hydro/pyonephrosis, significantly reduced renal size at ultrasound image, severe obesity (body mass index > 30), chronic kidney disease and acute kidney injury.
We enrolled all patients with serum creatinine less than 1.5 mg/dL and/or estimated glomerular filtration rate greater than 60 mL/min/1.73m2 and normal coagulation parameters, undergoing ultrasound-guided biopsy of native kidney, in our Unit, from August 2008 to December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline Solution | patients treated with 1 ml of s.c. saline solution |
| FG001 | DDAVP | treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline Solution | patients treated with 1 ml of s.c. saline solution |
| BG001 | DDAVP | treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. | Posted | Number | participants | Immediately post-biopsy and 24 hours post-biopsy. |
|
|
24 hours
heart rate was monitored every 6 hours after the biopsy for 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saline Solution | patients treated with 1 ml of s.c. saline solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild increase of heart rate | Cardiac disorders | Systematic Assessment |
A possible limitation of the study is the single-center design of the study, which could reduce the generalizability of our results and their external validity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlo Manno | University of Bari | 390805478878 | c.manno@nephro.uniba.it |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D003919 | Diabetes Insipidus |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| D014667 | Vasopressins |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| saline solution | Drug | saline solution 1 ml subcutaneous |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | DDAVP | treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy | 0 | 80 | 3 | 80 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |