Heart Valve SurgeryNCT07888634
Effects of Remote Ischemic Preconditioning at Different Time Phases in Patients Undergoing Heart Valve Surgery
A study testing remote ischemic preconditioning in people with Heart Valve Surgery and Acute Kidney Injury, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Patients undergoing heart valve surgery require cardiopulmonary bypass, a procedure that can lead to a temporary reduction in blood flow to major organs and subsequent ischemia-reperfusion injury, thereby triggering postoperative complications such as acute kidney injury and delirium. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Valve Surgery, Acute Kidney Injury
- What is being tested?
- remote ischemic preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years who are scheduled for elective CPB mitral and/or aortic valve surgery
Who cannot join
- Diagnosed with end-stage renal disease, chronic kidney disease stage 4-5, or have been receiving long-term renal replacement therapy
- Preoperative renal function impairment (eGFR < 30 ml·min-¹·1.73 m-²)
- Severe peripheral vascular disease, thrombosis, etc.
- History of mental illness or mild cognitive impairment (using Mini-Cog screening, score < 3)
- Combined surgical procedures (such as coronary artery bypass grafting, aortic dissection repair, and ascending aortic reconstruction) were excluded to minimize the potential impact of variations in surgical complexity on the risk of complications and the outcomes of the intervention
- Diagnosed with myocardial infarction, systemic infection, or sepsis within 7 days
- Participated in other clinical studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital, Fujian, Fuzhou 350000
Fuzhou, Fujian, 350000
Lin Yanjuan, +86 591 8621 8336, fjxhyjl@163.com
About this study
Official title: Effects of Remote Ischemic Preconditioning at Different Time Phases on Clinical Outcomes in Patients Undergoing Heart Valve Surgery
Patients undergoing heart valve surgery require cardiopulmonary bypass, a procedure that can lead to a temporary reduction in blood flow to major organs and subsequent ischemia-reperfusion injury, thereby triggering postoperative complications such as acute kidney injury and delirium. Current treatments for these complications primarily involve pharmacological and non-pharmacological interventions. Pharmacological interventions are not routinely employed due to limited supporting evidence, while non-pharmacological interventions are labor-intensive and lack systemic protective effects; thus, there is an urgent need for a systemic, non-pharmacological intervention that is easy to implement. This study aims to investigate the organ-protective effects of remote ischemic preconditioning-administered at different time points-following heart valve surgery, with the goal of developing a safe, effective, and clinically scalable nursing intervention protocol. Through this research, the investigators hope to further reduce the incidence of postoperative complications and improve clinical outcomes and prognoses for patients undergoing heart valve surgery.
- Conditions
- Heart Valve Surgery, Acute Kidney Injury
- Being tested
- remote 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 preconditioningDevice
The patient lies in the supine position, exposes the upper limbs, uses a sphygmomanometer, and ties the cuff to the upper limbs with a tightness that can accommodate one finger. The distance between the lower edge of the cuff and the antecubital space is 2cm. First, measure the patient's basal blood pressure. If the systolic blood pressure is less than 180mmHg, proceed to the next step of RIPC. In the same way, tie the compression therapy device cuff to the patient's upper limb, quickly pressurize to the pressure value of "basal systolic blood pressure + 50mmHg", maintain it for 5 minutes, and then quickly decompress to 0mmHg and maintain it for 5 minutes. This is an upper limb ischemia-reperfusion cycle. The ischemia-reperfusion procedure was repeated three times in total. The maximum pressure value during the operation shall not exceed 200mmHg. If the patient's systolic blood pressure is higher than 180mmHg or the hemodynamics is unstable, the intervention will be stopped.
| Study group | Role | What they receive |
|---|---|---|
| Delayed RIPC group | Experimental | Remote ischemic preconditioning intervention was performed 24±4 hours before surgery. Receives: Device: remote ischemic preconditioning |
| Combined RIPC group | Experimental | Two remote ischemic preconditioning interventions were performed 24±4 hours before surgery and again after anesthesia induction until the start of surgery. Receives: Device: remote ischemic preconditioning |
| Control group | No intervention | Routine care, without any special intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative acute kidney injury
Measured: From the date of surgery until the date of first documented AKI, assessed up to 7 days postoperatively.
Secondary outcomes (2)
the incidence of postoperative delirium
Measured: From the date of surgery until the date of first documented POD, assessed up to 7 days postoperatively.
mechanical ventilation duration
Measured: From the end of surgery until successful extubation, assessed up to 90 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve SurgeryStudies 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
- Outcomes assessor
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888634
- Sponsor's protocol ID
- 2026KY030
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Preconditioning at Different Time Phases on Clinical Outcomes in Patients Undergoing Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT07888634
- Acronym / sponsor ID
- 2026KY030
- Conditions
- Heart Valve Surgery, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Oct 2026 (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.
Patients undergoing heart valve surgery require cardiopulmonary bypass, a procedure that can lead to a temporary reduction in blood flow to major organs and subsequent ischemia-reperfusion injury, thereby triggering postoperative complications such as acute kidney injury and delirium. Current treatments for these complications primarily involve pharmacological and non-pharmacological interventions. Pharmacological interventions are not routinely employed due to limited supporting evidence, while non-pharmacological interventions are labor-intensive and lack systemic protective effects; thus, there is an urgent need for a systemic, non-pharmacological intervention that is easy to implement. This study aims to investigate the organ-protective effects of remote ischemic preconditioning-administered at different time points-following heart valve surgery, with the goal of developing a safe, effective, and clinically scalable nursing intervention protocol. Through this research, the investigators hope to further reduce the incidence of postoperative complications and improve clinical outcomes and prognoses for patients undergoing heart valve surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delayed RIPC group | Experimental | Device: remote ischemic preconditioningRemote ischemic preconditioning intervention was performed 24±4 hours before surgery. |
| Combined RIPC group | Experimental | Device: remote ischemic preconditioningTwo remote ischemic preconditioning interventions were performed 24±4 hours before surgery and again after anesthesia induction until the start of surgery. |
| Control group | No intervention | –Routine care, without any special intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥18 years who are scheduled for elective CPB mitral and/or aortic valve surgery
Key exclusion criteria (7 listed)
- Diagnosed with end-stage renal disease, chronic kidney disease stage 4-5, or have been receiving long-term renal replacement therapy
- Preoperative renal function impairment (eGFR < 30 ml·min-¹·1.73 m-²)
- Severe peripheral vascular disease, thrombosis, etc.
- History of mental illness or mild cognitive impairment (using Mini-Cog screening, score < 3)
- Combined surgical procedures (such as coronary artery bypass grafting, aortic dissection repair, and ascending aortic reconstruction) were excluded to minimize the potential impact of variations in surgical complexity on the risk of complications and the outcomes of the intervention
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 preconditioningThe patient lies in the supine position, exposes the upper limbs, uses a sphygmomanometer, and ties the cuff to the upper limbs with a tightness that can accommodate one finger. The distance between the lower edge of the cuff and the antecubital space is 2cm. First, measure the patient's basal blood pressure. If the systolic blood pressure is less than 180mmHg, proceed to the next step of RIPC. In the same way, tie the compression therapy device cuff to the patient's upper limb, quickly pressurize to the pressure value of "basal systolic blood pressure + 50mmHg", maintain it for 5 minutes, and then quickly decompress to 0mmHg and maintain it for 5 minutes. This is an upper limb ischemia-reperfusion cycle. The ischemia-reperfusion procedure was repeated three times in total. The maximum pressure value during the operation shall not exceed 200mmHg. If the patient's systolic blood pressure is higher than 180mmHg or the hemodynamics is unstable, the intervention will be stopped. | Device | Combined RIPC group, Delayed RIPC group |
Primary outcome
the incidence of postoperative acute kidney injury
Time frame: From the date of surgery until the date of first documented AKI, assessed up to 7 days postoperatively.
2 secondary outcomes
the incidence of postoperative delirium
Time frame: From the date of surgery until the date of first documented POD, assessed up to 7 days postoperatively.
mechanical ventilation duration
Time frame: From the end of surgery until successful extubation, assessed up to 90 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Valve Surgery
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Not yet recruiting
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA)
Not yet recruitingPhase 4
Superficial Parasternal Block Combined With Rectus Sheath Block for Open Cardiac Surgery
Cardiac Valve Disease, Coronary Heart Disease
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.
Fujian Medical University Union Hospital, Fujian, Fuzhou 350000
Fuzhou, 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 Heart Valve Surgery and Acute Kidney Injury, run by Fujian Medical University Union 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of postoperative acute kidney injury (time frame: From the date of surgery until the date of first documented AKI, assessed up to 7 days postoperatively.). 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 22 Oct 2026.