Prevention of Perioperative Acute Renal Failure

Madrid Health Service

Status and phase: Terminated; Phase 4

Conditions: Abdominal Surgery

Treatments: Drug: Isotonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00953940

Nefrane001

NºEudra CT: 2005-004755-35

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Isotonic saline

Experimental group

Description:

Isotonic saline

Treatment:

Drug: Isotonic saline

No treatment

No Intervention group

Description:

Habitual therapy