Acute Kidney InjuryNCT01316497
Acute Kidney Injury in Children Operated for Congenital Heart Disease
A study testing Remote ischemic preconditioning (RIPC) in people with Acute Kidney Injury, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study was to investigate if repeated inflation of a blood pressure cuff applied around one leg causing mild ischemia ("remote ischemic preconditioning") could protect children operated for congenital heart disease from developing acute kidney injury. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Remote ischemic preconditioning (RIPC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to Dec 2010
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children admitted for surgery for congenital heart disease
Who cannot join
- heart surgeries of low complexity such as closure of septal defects, aortico-pulmonary windows, establishment of glenn shunts, subaortic membrane resection, redirection of anomalous pulmonary veins, valvotomies, repair of pulmonary artery stenosis and surgeries without the use of extracorporeal circulation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Aarhus, 8200
About this study
The purpose of this study was to investigate if repeated inflation of a blood pressure cuff applied around one leg causing mild ischemia ("remote ischemic preconditioning") could protect children operated for congenital heart disease from developing acute kidney injury.
Read the detailed description
Remote ischemic preconditioning (RIPC) refers to an intervention of remote, brief ischemia which confers systemic protection against consequences of reperfusion injury in distant organs. RIPC has been shown to protect various organs during major surgeries. Our hypothesis was that RIPC could protect kidney function in children operated for complex congenital heart disease.
- Conditions
- Acute Kidney Injury
- Being tested
- Remote ischemic preconditioning (RIPC), Control
- Keywords
- Acute kidney injury, Ischemic preconditioning, Congenital heart defects, Cardiac surgical procedures, Infant, Child
- Medical subject headings
- Acute Kidney Injury, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioning (RIPC)Procedure or surgery
RIPC was performed by applying a blood pressure cuff around the child's leg. The cuff was inflated to 40 mmHg above the systolic pressure in 4 cycles of 5 minutes. Every cycle of ischemia was followed by 5 minutes of reperfusion. The first RIPC cycle started after anesthesia induction when invasive arterial blood pressure was monitored. Appropriate cuff size was used choosing between four sizes. For reproducibility RIPC was performed on the right leg with only a few exceptions, when the leg was used for invasive catheters.
ControlProcedure or surgery
The cuff was applied on the leg without inflation in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning (RIPC) | Experimental | See intervention description Receives: Procedure: Remote ischemic preconditioning (RIPC) |
| Control | Placebo comparator | Not described Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Categorized according to the RIFLE criteria (22): R= risk= increased p-creatinine * 1.5 and/or urine output < 0.5 ml/kg/hour for 6 hours, I= injury= increased p-creatinine * 2 and/or urine output < 0.5 ml/kg/hour for 12 hours, F= failure= increased p-creatinine * 3 or p-creatinine ≥ 350 µmol/L in the setting of an acute increase of at least 44 µmol/L and/or urine output < 0.3 ml/kg/hour for 24 hours or anuria for 12 hours, L= complete loss of renal function for > 4 weeks (need for dialysis for longer than 4 weeks), E= end-stage renal disease (need for dialysis for longer than 3 months).
Measured: Up to 4 days
Secondary outcomes (8)
Arterial blood pressure
Incidence of postoperative low blood pressure (below the age-reference level)
Measured: Up to 3 days
Inotropic Score (IS)
The highest postoperative daily dose (µg/kg//min) was used in the formula: IS = [(dopamine + dobutamine) × 1] + (milrinone × 10) + [(epinephrine + norepinephrine) × 100] to calculate the IS.
Measured: Up to 3 days
Reoperation during hospital stay
Measured: 90 days
Length of stay at the ICU
Measured: 90 days
Length of hospital stay
Measured: 90 days
Mortality
In-hospital mortality
Measured: 90 days
Level of cystatin C in plasma
Measured: Up to 4 days
Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionDec 2010
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 Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aase and Ejnar Danielsens Foundation, The Augustinus Foundation, Denmark., Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation, Helen and Ejnar Bjørnows Foundation, Raimond and Dagmar Ringgård-Bohn's Foundation, Grosserer L.F. Foghts Foundation, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, The Dagmar Marshall Foundation
- Responsible party
- Sponsor
- Investigators
- Kirsten MR Pedersen, MD, Study director, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, SkejbyVibeke E Hjortdal, MD PhD DMSc, Principal investigator, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, SkejbyHanne B Ravn, MD PhD, Study chair, Department of Anesthesia and Intensive Care, Aarhus University Hospital, SkejbyJohan V Povlsen, MD, Study chair, Department of Renal Medicine C, Aarhus University Hospital, SkejbyMichael R Schmidt, MD PhD, Study chair, Aarhus University HospitalErland Erlandsen, MSc, Study chair, Department of Clinical Biochemistry, Viborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316497
- Sponsor's protocol ID
- 20080052
- Status last verified
- Sep 2012
- First submitted
- 10 Mar 2011
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedersen KR, Povlsen JV, Christensen S, Pedersen J, Hjortholm K, Larsen SH, Hjortdal VE. Risk factors for acute renal failure requiring dialysis after surgery for congenital heart disease in children. Acta Anaesthesiol Scand. 2007 Nov;51(10):1344-9. doi: 10.1111/j.1399-6576.2007.01379.x.
PubMed 17944638Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
PubMed 16750696
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury in Children Operated for Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01316497
- Acronym / sponsor ID
- 20080052
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Ischemic preconditioning, Congenital heart defects, Cardiac surgical procedures, Infant, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aase and Ejnar Danielsens Foundation, The Augustinus Foundation, Denmark., Direktør Kurt Bønnelycke and Hustru fru Grethe Bønnelyckes Foundation, Helen and Ejnar Bjørnows Foundation, Raimond and Dagmar Ringgård-Bohn's Foundation, Grosserer L.F. Foghts Foundation, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, The Dagmar Marshall Foundation
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Mar 2011 (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 study was to investigate if repeated inflation of a blood pressure cuff applied around one leg causing mild ischemia ("remote ischemic preconditioning") could protect children operated for congenital heart disease from developing acute kidney injury.
Detailed description
Remote ischemic preconditioning (RIPC) refers to an intervention of remote, brief ischemia which confers systemic protection against consequences of reperfusion injury in distant organs. RIPC has been shown to protect various organs during major surgeries. Our hypothesis was that RIPC could protect kidney function in children operated for complex congenital heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning (RIPC) | Experimental | Procedure: Remote ischemic preconditioning (RIPC)See intervention description |
| Control | Placebo comparator | Procedure: Control |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children admitted for surgery for congenital heart disease
Key exclusion criteria (1 listed)
- heart surgeries of low complexity such as closure of septal defects, aortico-pulmonary windows, establishment of glenn shunts, subaortic membrane resection, redirection of anomalous pulmonary veins, valvotomies, repair of pulmonary artery stenosis and surgeries without the use of extracorporeal circulation
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 preconditioning (RIPC)RIPC was performed by applying a blood pressure cuff around the child's leg. The cuff was inflated to 40 mmHg above the systolic pressure in 4 cycles of 5 minutes. Every cycle of ischemia was followed by 5 minutes of reperfusion. The first RIPC cycle started after anesthesia induction when invasive arterial blood pressure was monitored. Appropriate cuff size was used choosing between four sizes. For reproducibility RIPC was performed on the right leg with only a few exceptions, when the leg was used for invasive catheters. | Procedure or surgery | Remote ischemic preconditioning (RIPC) |
| ControlThe cuff was applied on the leg without inflation in the control group. | Procedure or surgery | Control |
Primary outcome
Acute kidney injury
Time frame: Up to 4 days
Categorized according to the RIFLE criteria (22): R= risk= increased p-creatinine * 1.5 and/or urine output < 0.5 ml/kg/hour for 6 hours, I= injury= increased p-creatinine * 2 and/or urine output < 0.5 ml/kg/hour for 12 hours, F= failure= increased p-creatinine * 3 or p-creatinine ≥ 350 µmol/L in the setting of an acute increase of at least 44 µmol/L and/or urine output < 0.3 ml/kg/hour for 24 hours or anuria for 12 hours, L= complete loss of renal function for > 4 weeks (need for dialysis for longer than 4 weeks), E= end-stage renal disease (need for dialysis for longer than 3 months).
8 secondary outcomes
Arterial blood pressure
Time frame: Up to 3 days
Inotropic Score (IS)
Time frame: Up to 3 days
Reoperation during hospital stay
Time frame: 90 days
Length of stay at the ICU
Time frame: 90 days
Length of hospital stay
Time frame: 90 days
Mortality
Time frame: 90 days
Level of cystatin C in plasma
Time frame: Up to 4 days
Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine
Time frame: Up to 4 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 14 Sep 2012.
- Background: PubMed 17944638Pedersen KR, Povlsen JV, Christensen S, Pedersen J, Hjortholm K, Larsen SH, Hjortdal VE. Risk factors for acute renal failure requiring dialysis after surgery for congenital heart disease in children. Acta Anaesthesiol Scand. 2007 Nov;51(10):1344-9. doi: 10.1111/j.1399-6576.2007.01379.x.
- Background: PubMed 16750696Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
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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.
Kirsten MR Pedersen, MD study director
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Vibeke E Hjortdal, MD PhD DMSc principal investigator
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Hanne B Ravn, MD PhD study chair
Department of Anesthesia and Intensive Care, Aarhus University Hospital, Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning (RIPC) in people with Acute Kidney Injury, run by University of Aarhus at 1 site in Denmark.
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 1 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 14 Sep 2012. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Acute kidney injury (time frame: Up to 4 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 NCT01316497, 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 14 Sep 2012.