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NCT00953940 Clinical Trial

Prevention of Perioperative Acute Renal Failure

Abdominal Surgery Clinical Trial

Official title:
Prevention of Perioperative Acute Renal Failure in Abdominal Surgery

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00953940
Other study ID # Nefrane001
Secondary ID NºEudra CT: 2005
Status Terminated
Phase Phase 4
First received August 4, 2009
Last updated June 30, 2011
Start date June 2005
Est. completion date May 2011

Study information
Verified date August 2009
Source Hospital Universitario Ramon y Cajal
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial Summary

The purpose of this study is to measure the acute renal dysfunction on the first, second, seventh and twentieth days.

Recruitment information / eligibility
Status Terminated
Enrollment 600
Est. completion date May 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients who are undergoing elective abdominal surgery after appropriate information of the study, and its possible risks that may arise therefrom and that at any time to refuse their cooperation, give a written consent to participate in the study.

- Patients who at the time of the interview have an ASA between 2 and 4.

- Patients with chronic kidney failure mild moderate (serum creatinine between 1.5 and 3.0 mg / dl) can be included.

Exclusion Criteria:

- Chronic kidney diseases with serum creatinine higher than 3.0 mg /DL

- Laparoscopic abdominal surgery

- ASA 1 and ASA 5 patients.

- Patients with cardiac insufficiency, ascites and respiratory insufficiency

- Diastolic hypertension > 100 mmHg

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Isotonic saline
Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery

Locations
Country Name City State
Spain Hospital Ramon y Cajal Madrid

Sponsors (2)
Lead Sponsor Collaborator
Hospital Universitario Ramon y Cajal Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery. 5 years Yes
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