NCT00691756

Brief Summary

The purpose of this randomized trial was to determine whether renal perfusion with cold blood provides better protection against renal ischemia than perfusion with cold crystalloid in patients undergoing TAAA repair with left heart bypass.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.9 years

First QC Date

June 3, 2008

Last Update Submit

May 9, 2023

Conditions

Renal Failure

Keywords

renal failurethoracoabdominal aortic aneurysm repaircold crystalloidcold bloodrenal perfusion

Outcome Measures

Primary Outcomes (1)

  • Renal dysfunction

    10 postoperative days

Secondary Outcomes (1)

  • Renal injury (increase in urinary biomarkers)

    7 postoperative days

Study Arms (2)

1

EXPERIMENTAL

Cold blood renal perfusion

Procedure: Cold blood renal perfusion

2

ACTIVE COMPARATOR

Cold crystalloid renal perfusion

Procedure: Cold crystalloid renal perfusion

Interventions

Cold blood renal perfusionPROCEDURE

Both kidneys receive intermitent perfusion with cold (4 degrees C) autologous blood during thoracoabdominal aortic aneurysm repair.

1
Cold crystalloid renal perfusionPROCEDURE

Both kidneys receive intermittent perfusion with cold (4 degrees C) lactated Ringer's solution during thoracoabdominal aortic aneurysm repair. This is the standard renal perfusion technique in our practice.

2

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age equal to or greater than 18
  • planned extent II or III thoracoabdominal aortic aneurysm repair
  • planned left heart bypass
  • patient consent obtained

You may not qualify if:

  • impaired left ventricular function
  • impaired renal function
  • prior thoracoabdominal aortic aneurysm repair
  • pseudoaneurysm
  • pre-existing liver disease
  • free aortic aneurysm rupture
  • inability to measure renal temperature
  • extent I or IV thoracoabdominal aortic aneurysm repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Wu D, Coselli JS, Johnson ML, LeMaire SA. Hepatopancreaticobiliary Values after Thoracoabdominal Aneurysm Repair. Aorta (Stamford). 2014 Aug 1;2(4):135-42. doi: 10.12945/j.aorta.2014.14-015. eCollection 2014 Aug.

    PMID: 26798731BACKGROUND

  • Lemaire SA, Jones MM, Conklin LD, Carter SA, Criddell MD, Wang XL, Raskin SA, Coselli JS. Randomized comparison of cold blood and cold crystalloid renal perfusion for renal protection during thoracoabdominal aortic aneurysm repair. J Vasc Surg. 2009 Jan;49(1):11-9; discussion 19. doi: 10.1016/j.jvs.2008.08.048. Epub 2008 Nov 22.

    PMID: 19028052RESULT

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Scott A. LeMaire, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Surgery/Cardio/Thoracic Surg.

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

January 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)