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Prevention of Perioperative Acute Renal Failure

This study has been terminated.
(An external board recommended to close the study for futility after the interin analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953940
First Posted: August 6, 2009
Last Update Posted: July 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Universitario Ramon y Cajal
  Purpose
The purpose of this study is to measure the acute renal dysfunction on the first, second, seventh and twentieth days.

Condition Intervention Phase
Abdominal Surgery Drug: Isotonic saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Perioperative Acute Renal Failure in Abdominal Surgery

Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery. [ Time Frame: 5 years ]

Estimated Enrollment: 600
Study Start Date: June 2005
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isotonic saline
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953940


Locations
Spain
Hospital Ramon y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Dr Fernando Liaño, MD PhD Hospital Universitario Ramon y Cajal
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fernando Liaño García, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT00953940     History of Changes
Other Study ID Numbers: Nefrane001
NºEudra CT: 2005-004755-35
First Submitted: August 4, 2009
First Posted: August 6, 2009
Last Update Posted: July 4, 2011
Last Verified: August 2009

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases