Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

NCT ID: NCT06130436

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2024-08-09

Brief Summary

Our primary aim is to investigate whether perioperative remote ischemic conditioning (PRIC) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.

Detailed Description

Remote Ischemic Conditioning (RIC) can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. This protection can be applied prior to or during a prolonged ischemic event as remote ischemic pre-conditioning (RIPreC) and per-conditioning (RIPerC), respectively, or immediate after reperfusion as remote ischemic post-conditioning (RIPostC).

RIC is a non-pharmacologic and non-invasive treatment without noticeable discomfort, commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion. However, whether perioperative remote ischemic conditioning (PRIC) can improve postoperative recovery in patients undergoing hepatectomy has never been investigated in a randomized controlled trial.

Conditions

Hepatic Hemangioma; Liver Cancer; Hepatolithiasis; Hepatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham-Remote Ischemic Conditioning

Sham remote ischemic conditioning (Sham-RIC) is applied in the perioperative using an automated Sham-RIC device.

Group Type: SHAM_COMPARATOR

Sham-Remote Ischemic Conditioning

Intervention Type: DEVICE

Sham-Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.

Remote Ischemic Conditioning Once Daily

Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device once daily.

Group Type: ACTIVE_COMPARATOR

Remote Ischemic Conditioning Once Daily

Intervention Type: DEVICE

Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, the morning of the postoperative day 1, the morning of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg.

Sham-Remote Ischemic Conditioning (at the time points of 30 min after surgery, the afternoon of the postoperative day 1, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.

Remote Ischemic Conditioning Twice Daily

Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device twice daily.

Group Type: ACTIVE_COMPARATOR

Remote Ischemic Conditioning Twice Daily

Intervention Type: DEVICE

Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg.

Interventions

Sham-Remote Ischemic Conditioning

Sham-Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.

Intervention Type: DEVICE

Remote Ischemic Conditioning Once Daily

Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, the morning of the postoperative day 1, the morning of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg.

Sham-Remote Ischemic Conditioning (at the time points of 30 min after surgery, the afternoon of the postoperative day 1, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.

Intervention Type: DEVICE

Remote Ischemic Conditioning Twice Daily

Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing hepatectomy under general anesthesia
• American Society of Anesthesiology (ASA) grade of II ~ III
• Male and female patients, age 25 to 75 years
• New York Heart Association (NYHA) grade of I ~ III

Exclusion Criteria

• Patients with limb deformity or peripheral vascular disease affecting upper limb function
• Patients with a medical history of nervous system, immune system and mental illness
• Patients who have received hepatectomy in the past, have important organ diseases or have undergone surgical treatment recently
• Patients who have recently used anti-inflammatory analgesics, anticoagulants, hormone drugs, immunosuppressants, and ATP-sensitive K-channel blockers (KATP)
• Preoperative severe renal insufficiency (serum creatinine > 442 umol/L, with or without serum potassium > 6.5 mmol/L, or the clinician-recognized need for renal replacement therapy), liver insufficiency (Child-Pugh grade C)
• Patients and/or their family members refuse to participate in the program

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

He Huang, ph.D

Role: STUDY_CHAIR

The Second Affiliated Hospital, Chongqing Medical University

Locations

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, , China

Countries

China

References

Tian C, Tian H, Li W, Chen J, Guo Q, Duan G, Huang H. Effects of Remote Ischemic Conditioning on Postoperative Recovery After Hepatectomy: A Randomised Controlled Trial. Liver Int. 2025 Mar;45(3):e70041. doi: 10.1111/liv.70041.

Reference Type: DERIVED

PMID: 39982031 (View on PubMed)

Other Identifiers

PRIC

Identifier Type: -

Identifier Source: org_study_id