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RecruitingNCT07888634Updated Oct 22, 2026

Effects of Remote Ischemic Preconditioning at Different Time Phases in Patients Undergoing Heart Valve Surgery

An interventional study of remote ischemic preconditioning in Heart Valve Surgery and Acute Kidney Injury, sponsored by Fujian Medical University Union Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Fujian Medical University Union Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2026, registered Oct 2026).
  • Started Mar 2026; still recruiting 7 months later.
Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
291
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Heart Valve Surgery
  • Acute Kidney Injury

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03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's planned enrollment of 291 is above the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 104 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged ≥18 years who are scheduled for elective CPB mitral and/or aortic valve surgery

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
291 participants (estimated)

Study arms

  • Experimental
    Delayed RIPC group

    Remote ischemic preconditioning intervention was performed 24±4 hours before surgery.

    Device: remote ischemic preconditioning

  • Experimental
    Combined RIPC group

    Two remote ischemic preconditioning interventions were performed 24±4 hours before surgery and again after anesthesia induction until the start of surgery.

    Device: remote ischemic preconditioning

  • No intervention
    Control group

    Routine care, without any special intervention.

Interventions

  • Deviceremote ischemic preconditioning

    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.

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. mechanical ventilation duration

    Time frame: From the end of surgery until successful extubation, assessed up to 90 days postoperatively.

07

Study locations

1 of 1 sites recruiting
  • Fujian Medical University Union Hospital, Fujian, Fuzhou 350000
    Fuzhou, Fujian 350000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

Of 239 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 44. This study's planned 9 months is below that.

Counting every sponsor, half of 255 studies reached it within 26 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 22, 2026
StartActual
Mar 1, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07888634
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Mar 1, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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