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.
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.
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cold blood renal perfusion Receives: Procedure: Cold blood renal perfusion |
| 2 | Active comparator | Cold 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.
Renal dysfunction
Measured: 10 postoperative days
Secondary outcomes (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.
- First posted5 Jun 2008 (estimated)
- Study startJan 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Gillson-Longenbaugh Foundation, Texas Heart Institute
- Responsible party
- Principal investigator, Scott Lemaire, Baylor College of Medicine
- Investigators
- Scott A. LeMaire, MD, Principal investigator, Baylor College of Medicine
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 26798731Lemaire 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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00691756
- Acronym / sponsor ID
- H-9764
- Conditions
- Renal Failure
- Keywords
- renal failure, thoracoabdominal aortic aneurysm repair, cold crystalloid, cold blood, renal perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Gillson-Longenbaugh Foundation, Texas Heart Institute
- Study start
- Jan 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Cold blood renal perfusionCold blood renal perfusion |
| 2 | Active comparator | Procedure: Cold crystalloid renal perfusionCold crystalloid renal perfusion |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age equal to or greater than 18
- planned extent II or III thoracoabdominal aortic aneurysm repair
- planned left heart bypass
- patient consent obtained
Key exclusion criteria (8 listed)
- impaired left ventricular function
- impaired renal function
- prior thoracoabdominal aortic aneurysm repair
- pseudoaneurysm
- pre-existing liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold blood renal perfusionBoth kidneys receive intermitent perfusion with cold (4 degrees C) autologous blood during thoracoabdominal aortic aneurysm repair. | Procedure or surgery | 1 |
| Cold crystalloid renal perfusionBoth 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. | Procedure or surgery | 2 |
Primary outcome
Renal dysfunction
Time frame: 10 postoperative days
1 secondary outcome
Renal injury (increase in urinary biomarkers)
Time frame: 7 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 26798731Wu 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.
- Results publication: PubMed 19028052Lemaire 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott A. LeMaire, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
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.