Acute Kidney InjuryRenRIPC-TARNCT03141385
Renal Effects of RIPC in Patients After Total Arch Replacement
A study testing remote ischemic preconditioning in people with Acute Kidney Injury and Dialysis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Dialysis
- What is being tested?
- remote ischemic preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2017to 30 May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for total arch replacement
- written informed consent
Who cannot join
- pre-existing AKI
- peripheral vascular disease affecting the upper limbs
- hybrid total arch replacement
- the history of kidney transplantation
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
Beijing
About this study
Official title: Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement
The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.
Read the detailed description
Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.
- Conditions
- Acute Kidney Injury, Dialysis
- Being tested
- remote ischemic preconditioning, Control
- 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 preconditioningOther
Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)
ControlOther
Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.
| Study group | Role | What they receive |
|---|---|---|
| RIPC intervention | Experimental | Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation) Receives: Other: remote ischemic preconditioning |
| Control | Sham comparator | Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI within the 7 days after the surgery
AKI defined by KDIGO criteria
Measured: Within 7 days after the surgery
Secondary outcomes (7)
Incidence of severe AKI (stage 2 and stage 3)
severity defined by KDIGO criteria
Measured: Within 7 days after the surgery
Renal replacement therapy
the requirement for RRT during index hospital stay
Measured: Within 30 days after the surgery
Mechanical ventilation duration
duration of mechanical ventilation in the intensive care unit
Measured: Within 30 days after the surgery
Length of intensive care unit stay
length of stay on the intensive care unit
Measured: Within 30 days after the surgery
In-hospital death
in-hospital all-cause death
Measured: Within 30 days after the surgery
Stroke
new onset stroke during index hospital stay
Measured: Within 30 days after the surgery
Paraplegia
impairment in motor or sensory function of the lower extremities during index hospital stay
Measured: Within 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start7 Apr 2017
- Primary completion1 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Guyan Wang, PhD, Principal investigator, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141385
- Sponsor's protocol ID
- FW2016-F09
- Acronym
- RenRIPC-TAR
- Status last verified
- Jul 2018
- First submitted
- 3 May 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
PubMed 36645250Chen Y, Wang G, Zhou H, Yang L, Zhang C, Yang X, Lei G. 90 days impacts of remote ischemic preconditioning on patients undergoing open total aortic arch replacement: a post-hoc analysis of previous trial. BMC Anesthesiol. 2020 Jul 9;20(1):169. doi: 10.1186/s12871-020-01085-9.
PubMed 32646379Zhou H, Yang L, Wang G, Zhang C, Fang Z, Lei G, Shi S, Li J. Remote Ischemic Preconditioning Prevents Postoperative Acute Kidney Injury After Open Total Aortic Arch Replacement: A Double-Blind, Randomized, Sham-Controlled Trial. Anesth Analg. 2019 Jul;129(1):287-293. doi: 10.1213/ANE.0000000000004127.
PubMed 30896603
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement
- ClinicalTrials.gov ID
- NCT03141385
- Acronym / sponsor ID
- RenRIPC-TAR / FW2016-F09
- Conditions
- Acute Kidney Injury, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 5 May 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.
The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.
Detailed description
Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC intervention | Experimental | Other: remote ischemic preconditioningRemote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation) |
| Control | Sham comparator | Other: ControlFour cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for total arch replacement
- written informed consent
Key exclusion criteria (4 listed)
- pre-existing AKI
- peripheral vascular disease affecting the upper limbs
- hybrid total arch replacement
- the history of kidney transplantation
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 preconditioningRemote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation) | Other | RIPC intervention |
| ControlFour cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated. | Other | Control |
Primary outcome
Incidence of AKI within the 7 days after the surgery
Time frame: Within 7 days after the surgery
AKI defined by KDIGO criteria
7 secondary outcomes
Incidence of severe AKI (stage 2 and stage 3)
Time frame: Within 7 days after the surgery
Renal replacement therapy
Time frame: Within 30 days after the surgery
Mechanical ventilation duration
Time frame: Within 30 days after the surgery
Length of intensive care unit stay
Time frame: Within 30 days after the surgery
In-hospital death
Time frame: Within 30 days after the surgery
Stroke
Time frame: Within 30 days after the surgery
Paraplegia
Time frame: Within 30 days after the surgery
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 11 Jul 2018.
- Derived from this study: PubMed 36645250Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
- Derived from this study: PubMed 32646379Chen Y, Wang G, Zhou H, Yang L, Zhang C, Yang X, Lei G. 90 days impacts of remote ischemic preconditioning on patients undergoing open total aortic arch replacement: a post-hoc analysis of previous trial. BMC Anesthesiol. 2020 Jul 9;20(1):169. doi: 10.1186/s12871-020-01085-9.
- Derived from this study: PubMed 30896603Zhou H, Yang L, Wang G, Zhang C, Fang Z, Lei G, Shi S, Li J. Remote Ischemic Preconditioning Prevents Postoperative Acute Kidney Injury After Open Total Aortic Arch Replacement: A Double-Blind, Randomized, Sham-Controlled Trial. Anesth Analg. 2019 Jul;129(1):287-293. doi: 10.1213/ANE.0000000000004127.
- Individual participant dataSharing planned: Undecided
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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.
Guyan Wang, PhD principal investigator
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China
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 in people with Acute Kidney Injury and Dialysis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 2 inclusion and 4 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 11 Jul 2018. 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 China. 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 AKI within the 7 days after the surgery (time frame: Within 7 days after the surgery). 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 NCT03141385, which also lists 3 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 11 Jul 2018.