Acute Kidney InjuryNCT03205410
Remote Ischemic Preconditioning as a New Method of Nephroprotection
A study testing remote ischemic preconditioning and no - remote ischemic preconditioning in people with Acute Kidney Injury, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- remote ischemic preconditioning and no - remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2014to 31 Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Human patients with coronary artery disease.
Who cannot join
- history of cardiac surgery,
- acute myocardial infarction up to 7 days before surgery,
- chronic kidney disease in 4th or 5th stadium (eGFR<30 ml/min/1,73m2),
- peripheral vascular disease affecting upper limbs,
- history of severe injuries and surgeries in 2 months before cardiac surgery,
- history of cancer, acute inflammation during hospitalization,
- chronic autoimmunology diseases,
- dialysis patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery
Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way using serum creatinine concentration (SCr) and with use of serum level of neutrophil gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury. Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).
Read the detailed description
Cardiac surgery patients have a high risk of AKI. The development of AKI is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. However, there are no effective clinical strategies for preventing prevalence of AKI. RIPC as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. That makes RIPC under the area of interests of many researches which apply this method to prevent AKI. Investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative AKI, in which want to check wether RIPC reduce the prevalence of AKI, according Kidney Disease: Improving Global Outcomes (KDIGO) definition, by increase in SCr. Furthermore researchers want to investigate a benefit from RIPC in reduction of level of SCr and higher glomerular filtration rate (GFR) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of NGAL an early biomarker of AKI.
- Conditions
- Acute Kidney Injury
- Being tested
- remote ischemic preconditioning, no - remote ischemic preconditioning
- Keywords
- remote ischemic preconditioning, cardiac surgery-associated acute kidney injury, neutrophil gelatinase-associated lipocalin
- 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
Also called RIPC
The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
no - remote ischemic preconditioningProcedure or surgery
Also called no-RIPC
The sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients with RIPC | Experimental | intervention: remote ischemic preconditioning - three cycles of 5-min ischemia, achieved by inflation of blood-pressure cuff to 200 mmHg, followed by 5-min reperfusion while the cuff was deflated were applied to the upper left arm. Receives: Procedure: remote ischemic preconditioning |
| Patients without RIPC | Sham comparator | intervention: no - remote ischemic preconditioning - in controls, the cuff was placed around the arm but not inflated. Receives: Procedure: no - remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute kidney injury within 72 hours after cardiac surgery
increase in serum creatinine level by more than 50% or more than 0.3mg/dL from baseline within 72 h after surgery
Measured: 72 hours after cardiac surgery
NGAL level
increased NGAL level within 3 hours after cardiac surgery
Measured: 3 hours after cardiac surgery
Secondary outcomes (6)
length of hospitalization
time until discharge from the hospital
Measured: through hospitalization completion, an average of 14 days
length of intensive care unit (ICU) stay
time until discharge from ICU
Measured: through ICU stay completion, an average of 5 days
ventilation time
time of mechanical ventilation
Measured: through ICU stay completion, an average of 5 days
occurrence of postoperative atrial fibrillation
incidence of atrial fibrylation in continous electrocardiogram registration
Measured: through ICU stay completion, an average of 5 days
time of renal replacement therapy
days of renal replacement therapy
Measured: through ICU stay completion, an average of 5 days
death
death from any cause
Measured: from date of randomization until the date of death from any cause, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jan 2014
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Stokfisz, Medical University of Lodz
- Investigators
- Marzenna Zielinska, MD,PhD,Prof., Study chair, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205410
- Sponsor's protocol ID
- RNN/286/13/KE
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current status of the study are available from the corresponding author on reasonable request.
Publications
Stokfisz K, Ledakowicz-Polak A, Zagorski M, Jander S, Przybylak K, Zielinska M. The clinical utility of remote ischemic preconditioning in protecting against cardiac surgery-associated acute kidney injury: A pilot randomized clinical trial. Adv Clin Exp Med. 2020 Feb;29(2):189-196. doi: 10.17219/acem/112610.
PubMed 32091672
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03205410
- Acronym / sponsor ID
- RNN/286/13/KE
- Conditions
- Acute Kidney Injury
- Keywords
- remote ischemic preconditioning, cardiac surgery-associated acute kidney injury, neutrophil gelatinase-associated lipocalin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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.
Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way using serum creatinine concentration (SCr) and with use of serum level of neutrophil gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury. Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).
Detailed description
Cardiac surgery patients have a high risk of AKI. The development of AKI is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. However, there are no effective clinical strategies for preventing prevalence of AKI. RIPC as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. That makes RIPC under the area of interests of many researches which apply this method to prevent AKI. Investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative AKI, in which want to check wether RIPC reduce the prevalence of AKI, according Kidney Disease: Improving Global Outcomes (KDIGO) definition, by increase in SCr. Furthermore researchers want to investigate a benefit from RIPC in reduction of level of SCr and higher glomerular filtration rate (GFR) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of NGAL an early biomarker of AKI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with RIPC | Experimental | Procedure: remote ischemic preconditioningintervention: remote ischemic preconditioning - three cycles of 5-min ischemia, achieved by inflation of blood-pressure cuff to 200 mmHg, followed by 5-min reperfusion while the cuff was deflated were applied to the upper left arm. |
| Patients without RIPC | Sham comparator | Procedure: no - remote ischemic preconditioningintervention: no - remote ischemic preconditioning - in controls, the cuff was placed around the arm but not inflated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Human patients with coronary artery disease.
Key exclusion criteria (8 listed)
- history of cardiac surgery,
- acute myocardial infarction up to 7 days before surgery,
- chronic kidney disease in 4th or 5th stadium (eGFR<30 ml/min/1,73m2),
- peripheral vascular disease affecting upper limbs,
- history of severe injuries and surgeries in 2 months before cardiac surgery,
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 preconditioningAlso: RIPCThe remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery. | Procedure or surgery | Patients with RIPC |
| no - remote ischemic preconditioningAlso: no-RIPCThe sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery. | Procedure or surgery | Patients without RIPC |
Primary outcome
incidence of acute kidney injury within 72 hours after cardiac surgery
Time frame: 72 hours after cardiac surgery
increase in serum creatinine level by more than 50% or more than 0.3mg/dL from baseline within 72 h after surgery
NGAL level
Time frame: 3 hours after cardiac surgery
increased NGAL level within 3 hours after cardiac surgery
6 secondary outcomes
length of hospitalization
Time frame: through hospitalization completion, an average of 14 days
length of intensive care unit (ICU) stay
Time frame: through ICU stay completion, an average of 5 days
ventilation time
Time frame: through ICU stay completion, an average of 5 days
occurrence of postoperative atrial fibrillation
Time frame: through ICU stay completion, an average of 5 days
time of renal replacement therapy
Time frame: through ICU stay completion, an average of 5 days
death
Time frame: from date of randomization until the date of death from any cause, assessed up to 2 years
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 2 Jul 2017.
- Derived from this study: PubMed 32091672Stokfisz K, Ledakowicz-Polak A, Zagorski M, Jander S, Przybylak K, Zielinska M. The clinical utility of remote ischemic preconditioning in protecting against cardiac surgery-associated acute kidney injury: A pilot randomized clinical trial. Adv Clin Exp Med. 2020 Feb;29(2):189-196. doi: 10.17219/acem/112610.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current status of the study are available from the corresponding author on reasonable request.
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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.
Marzenna Zielinska, MD,PhD,Prof. study chair
Medical University of Lodz
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 and no - remote ischemic preconditioning in people with Acute Kidney Injury, run by Medical University of Lodz at 1 site in Poland.
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 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 2 Jul 2017. 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 Poland. 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?
incidence of acute kidney injury within 72 hours after cardiac surgery (time frame: 72 hours after cardiac surgery). The study lists 2 primary outcomes in all. 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 NCT03205410, which also lists 1 linked publication.
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 2 Jul 2017.