Acute Kidney InsufficiencyPhase 1NCT00821522
The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery
A Phase 1 study testing Remote Ischemic Preconditioning in people with Acute Kidney Insufficiency and Acute Renal Insufficiency, run by Robert Kramer, MD at 1 site in United States.
Trial summary
Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to May 2010
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing heart surgery on cardiopulmonary bypass.
Who cannot join
- Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.
- End-stage renal disease.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.
- Conditions
- Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Ischemic Preconditioning
- Being tested
- Remote Ischemic Preconditioning
- Keywords
- Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Cardiac Surgical Procedures, Ischemic Preconditioning
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningProcedure or surgery
Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| Preconditioning | Active comparator | Not described Receives: Procedure: Remote Ischemic Preconditioning |
| Control | No intervention | Standard clinical management during cardiac surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl.
Measured: 48 hours after surgery.
Secondary outcomes (2)
Oliguria.
Measured: 12 hours after surgery.
Incidence of acute kidney injury as defined by post-operative elevation in NGAL.
Measured: 3 hours after cardiopulmonary bypass.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InsufficiencyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Kramer, MD
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth
- Responsible party
- Sponsor-investigator, Robert Kramer, MD, MaineHealth
- Investigators
- Robert F Zimmerman, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821522
- Sponsor's protocol ID
- 3401
- Status last verified
- Nov 2021
- First submitted
- 9 Jan 2009
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00821522
- Acronym / sponsor ID
- 3401
- Conditions
- Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Ischemic Preconditioning
- Keywords
- Acute Kidney Insufficiency, Acute Renal Insufficiency, Acute Kidney Injury, Cardiac Surgical Procedures, Ischemic Preconditioning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Robert Kramer, MDUniversity, hospital or other
- Collaborators
- MaineHealth
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 Jan 2009 (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.
Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preconditioning | Active comparator | Procedure: Remote Ischemic Preconditioning |
| Control | No intervention | –Standard clinical management during cardiac surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing heart surgery on cardiopulmonary bypass.
Key exclusion criteria (3 listed)
- Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.
- End-stage renal disease.
- Inability to give informed consent.
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 |
|---|---|---|
| Remote Ischemic PreconditioningThree 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass. | Procedure or surgery | Preconditioning |
Primary outcome
Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl.
Time frame: 48 hours after surgery.
2 secondary outcomes
Oliguria.
Time frame: 12 hours after surgery.
Incidence of acute kidney injury as defined by post-operative elevation in NGAL.
Time frame: 3 hours after cardiopulmonary bypass.
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 17 Nov 2021.
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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.
Robert F Zimmerman, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Remote Ischemic Preconditioning in people with Acute Kidney Insufficiency and Acute Renal Insufficiency, run by Robert Kramer, MD 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 1 inclusion and 3 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 17 Nov 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl. (time frame: 48 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2021.