Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

Chongqing Medical University

Status: Completed

Conditions: Hepatic Hemangioma; Hepatectomy; Hepatolithiasis; Liver Cancer

Treatments: Device: Remote Ischemic Conditioning Once Daily; Device: Sham-Remote Ischemic Conditioning; Device: Remote Ischemic Conditioning Twice Daily

Study type: Interventional

Funder types: Other

Identifiers

NCT06130436

PRIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 3 patient groups

Sham-Remote Ischemic Conditioning

Sham Comparator group

Description:

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

Treatment:

Device: Sham-Remote Ischemic Conditioning

Remote Ischemic Conditioning Once Daily

Active Comparator group

Description:

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

Treatment:

Device: Remote Ischemic Conditioning Once Daily

Remote Ischemic Conditioning Twice Daily

Active Comparator group

Description:

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

Treatment:

Device: Remote Ischemic Conditioning Twice Daily