Prevention of Intradialytic Hypotension in Acute Kidney I... | NCT00971971

Studies
Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients

NCT00971971

Sponsor

Sao Jose do Rio Preto Medical School

Status

Completed

Last Update Posted

Sep 7, 2009Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Acute Kidney Injury
Acute Renal Failure

Interventions

Dialysis
Standard SLED

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Sep 2009Actual

First Submitted Date

Sep 3, 2009

First Submission Date that Met QC Criteria

Sep 3, 2009

First Posted Date

Sep 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2009

Last Update Posted Date

Sep 7, 2009Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Traditional SLED	Procedure: Standard SLED
Profiling	Experimental	dialysate temperature reduction with Na and ultrafiltration (UF) profiling	Procedure: Dialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dialysis	Procedure	dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling	Profiling

Measure	Description	Time Frame
Intradialytic hypotension		At dialysis session

Measure	Description	Time Frame
Dialysis dose		dialysis session

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
São Jose do Rio Preto Medical School		São José do Rio Preto	São Paulo	15090-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D007022	Hypotension

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003956	Dialysis

Ancestor Terms

ID	Term
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D055598	Chemical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided