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Renal FailureNCT00691756

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

A study testing Cold blood renal perfusion and Cold crystalloid renal perfusion in people with Renal Failure, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Renal Failure
What is being tested?
Cold blood renal perfusion and Cold crystalloid renal perfusion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteUnited States
Study dates
Jan 2002to Dec 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Renal Failure
Being tested
Cold blood renal perfusion, Cold crystalloid renal perfusion
Keywords
renal failure, thoracoabdominal aortic aneurysm repair, cold crystalloid, cold blood, renal perfusion
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold blood renal perfusionProcedure or surgery

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

  • Cold crystalloid renal perfusionProcedure or surgery

    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.

Study groups in NCT00691756
Study groupRoleWhat they receive
1ExperimentalCold blood renal perfusion
Receives: Procedure: Cold blood renal perfusion
2Active comparatorCold crystalloid renal perfusion
Receives: Procedure: Cold crystalloid renal perfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal dysfunction

    Measured: 10 postoperative days

Secondary outcomes (1)
  1. Renal injury (increase in urinary biomarkers)

    Measured: 7 postoperative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2008 (estimated)
  2. Study startJan 2002
  3. Primary completionDec 2006
  4. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00691756
Sponsor's protocol ID
H-9764
Status last verified
May 2023
First submitted
3 Jun 2008
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26798731
  • 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.

    PubMed 19028052

Questions about this trial

What is this clinical trial studying?

A study testing Cold blood renal perfusion and Cold crystalloid renal perfusion in people with Renal Failure, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal dysfunction (time frame: 10 postoperative days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00691756, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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