Prevention of Perioperative Acute Renal Failure

Prevention of Perioperative Acute Renal Failure in Abdominal Surgery

Sponsors

Lead Sponsor: Hospital Universitario Ramon y Cajal

Collaborator: Fondo de Investigacion Sanitaria

Source Hospital Universitario Ramon y Cajal
Brief Summary

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

Overall Status Terminated
Start Date June 2005
Completion Date May 2011
Primary Completion Date February 2011
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery. 5 years
Enrollment 600
Condition
Intervention

Intervention Type: Drug

Intervention Name: Isotonic saline

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

Arm Group Label: Isotonic saline

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dr Fernando Liaño, MD PhD Principal Investigator Hospital Universitario Ramon y Cajal
Location
Facility: Hospital Ramon y Cajal
Location Countries

Spain

Verification Date

August 2009

Responsible Party

Name Title: Fernando Liaño García

Organization: Hospital Universitario Ramon y Cajal

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Isotonic saline

Type: Experimental

Description: Isotonic saline

Label: No treatment

Type: No Intervention

Description: Habitual therapy

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov