Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients

September 4, 2009 updated by: Sao Jose do Rio Preto Medical School

Assessment of a Protocol Aiming to Prevent Intradialytic Hypotension in Critically Ill Acute Kidney Injury Patients

Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI) patients submitted to sustained low-efficiency dialysis (SLED).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Jose do Rio Preto, SP, Brazil, 15090-000
        • Sao Jose do Rio Preto Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Acute renal failure with a need of dialysis.

Exclusion Criteria:

  • Patients with basal serum creatinine > 3 mgdL.
  • Patients submitted to renal transplantation.
  • Patients unlikely to survive.
  • Declination in authorization to participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Traditional SLED
Procedure: Standard SLED
Experimental: Profiling
dialysate temperature reduction with Na and ultrafiltration (UF) profiling
Procedure: Dialysis
dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intradialytic hypotension
Time Frame: At dialysis session
At dialysis session

Secondary Outcome Measures

Outcome Measure
Time Frame
Dialysis dose
Time Frame: dialysis session
dialysis session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sao Jose do Rio Preto Medical School

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Estimate)

September 7, 2009

Last Update Submitted That Met QC Criteria

September 4, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10727-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe