Prevention of Perioperative Acute Renal Failure

Prevention of Perioperative Acute Renal Failure in Abdominal Surgery

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

Study Overview

• Status: Terminated
• Conditions: Abdominal Surgery
• Intervention / Treatment: Drug: Isotonic saline

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isotonic saline	Drug: Isotonic saline; Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery
No Intervention: No treatment; Habitual therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery.	5 years

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal
• Collaborators: Fondo de Investigacion Sanitaria
• Investigators: Principal Investigator: Dr Fernando Liaño, MD PhD, Hospital Universitario Ramón y Cajal

Publications and helpful links

General Publications

• Serrano AB, Candela-Toha AM, Zamora J, Vera J, Muriel A, Del Rey JM, Liano F. Preoperative hydration with 0.9% normal saline to prevent acute kidney injury after major elective open abdominal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jun;33(6):436-43. doi: 10.1097/EJA.0000000000000421.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 4, 2009
• First Submitted That Met QC Criteria: August 5, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Estimate): July 4, 2011
• Last Update Submitted That Met QC Criteria: June 30, 2011
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: Nefrane001; NºEudra CT: 2005-004755-35