Prevention of Perioperative Acute Renal Failure

NCT ID: NCT00953940

Last Updated: 2011-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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Conditions

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Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Isotonic saline

Isotonic saline

Group Type EXPERIMENTAL

Isotonic saline

Intervention Type DRUG

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

No treatment

Habitual therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Isotonic saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondo de Investigacion Sanitaria

OTHER

Sponsor Role collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Hospital Universitario Ramon y Cajal

Principal Investigators

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Dr Fernando Liaño, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Locations

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Hospital Ramon y Cajal

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 26825017 (View on PubMed)

Other Identifiers

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NºEudra CT: 2005-004755-35

Identifier Type: -

Identifier Source: secondary_id

Nefrane001

Identifier Type: -

Identifier Source: org_study_id

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