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A Comparison of Renal Perfusion in Thoracoabdominal Aortic Aneurysm (TAAA) Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691756
First Posted: June 5, 2008
Last Update Posted: June 5, 2008
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.
Collaborators:
Gillson Longenbaugh Foundation
Texas Heart Institute
Information provided by:
Baylor College of Medicine
June 3, 2008
June 5, 2008
June 5, 2008
January 2002
December 2006   (Final data collection date for primary outcome measure)
Renal dysfunction [ Time Frame: 10 postoperative days ]
Same as current
No Changes Posted
Renal injury (increase in urinary biomarkers) [ Time Frame: 7 postoperative days ]
Same as current
Not Provided
Not Provided
 
A Comparison of Renal Perfusion in Thoracoabdominal Aortic Aneurysm (TAAA) Repair
A Comparison of Cold Blood Versus Cold Crystalloid Renal Perfusion for Prevention of Acute Renal Failure Following Thoracoabdominal Aortic Aneurysm Repair: A Randomized Study
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.
Despite improvements in surgical techniques and postoperative care, renal dysfunction has consistently remained a significant and potentially lethal complication after thoracoabdominal aortic aneurysm (TAAA) repair. In an attempt to alleviate postoperative renal failure and its associated mortality, several techniques and intraoperative strategies have been used including: intraoperative administration of diuretics, steroids, or prostaglandins; minimization of ischemic times; renal hypothermia with cold crystallid solutions; selective warm (normothermic) blood perfusion as part of a left heart bypass (LHB) system; and hemodilution. However, despite the use of adjuvant techniques, the incidence of renal failure after TAAA repair still ranges from 3% to 27%. One of the techniques mentioned above involves cold crystalloid renal artery perfusion. This method aims to reduce metabolic needs of the renal system by inducing local hypothermia. Because oxygen consumption decreases 7% for each degree Celsius that temperature is reduced, the metabolic needs of tubular cells are reduced by almost 50% at 30 degrees Celsius. After the aorta is clamped and opened, the renal arteries are perfused with lactated Ringers solution (LR) that has been cooled to 4 degrees Celsius utilizing a roller pump to transport the LR through an appropriately cooled ice bath. This decreases the temperature of the kidneys to an average of 20 degrees Celsius. The volume of LR required to achieve this temperature ranges from 600 to 1800 ml. Renal cooling has been shown to preserve renal tissue as long as warm ischemic time is kept to a minimum. We recently compared renal artery cold crystalloid perfusion with normothermic blood perfusion in a randomized clinical trial involving 30 patients and discovered via multivariable analysis that cold LR was protective against acute postoperative renal dysfunction. In this study, we found that 62.5% of patients receiving normothermic blood perfusion developed acute postoperative renal dysfunction versus 21.4% in the cold LR group (p = 0.03). One method of renal protection not often used involves selective cold blood perfusion of the renal arteries. This technique also aims to reduce renal ischemic time during aortic cross-clamping and improve oxygenation to renal tissues; thereby, preventing reperfusion injury and organ dysfunction often associated with this operation. During aneurysm repair, left atrio-distal aortic bypass is performed using a centrifugal pump. Tubing connected to the distal end of this circuit passes through a container of ice allowing the perfusion of both renal arteries with cold blood. The flow rates into the renal arteries range from 100 to 450 ml/min. The celiac axis and superior mesenteric artery remain individually perfused in the standard fashion using normothermic blood. The best method of achieving renal protection remains unclear. Currently, normothermic blood and cold LR remain the two most commonly used methods of renal artery perfusion during TAAA repair. This randomized trial compared the effectiveness of two forms of renal artery perfusion, cold LR versus cold blood, to identify which method is more beneficial in the prevention of postoperative renal dysfunction.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Renal Failure
  • Procedure: Cold blood renal perfusion
    Both kidneys receive intermitent perfusion with cold (4 degrees C) autologous blood during thoracoabdominal aortic aneurysm repair.
  • Procedure: Cold crystalloid renal perfusion
    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.
  • Experimental: 1
    Cold blood renal perfusion
    Intervention: Procedure: Cold blood renal perfusion
  • Active Comparator: 2
    Cold crystalloid renal perfusion
    Intervention: Procedure: Cold crystalloid renal perfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
December 2006
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00691756
H-9764
No
Not Provided
Not Provided
Scott A. LeMaire, MD, Baylor College of Medicine
Baylor College of Medicine
  • Gillson Longenbaugh Foundation
  • Texas Heart Institute
Principal Investigator: Scott A. LeMaire, MD Baylor College of Medicine
Baylor College of Medicine
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP