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Completed

NCT Number: NCT06130436

Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham-Remote Ischemic Conditioning

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

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

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.

Primary outcomes

  1. Alanine aminotransferase (ALT)

    Time frame: 7 days

    The levels of ALT in perioperative period

Secondary outcomes

  1. Aspartate aminotransferase (AST)

    Time frame: 7 days

    The levels of AST in perioperative period

  2. Total bilirubin (TBIL)

    Time frame: 7 days

    The levels of TBIL in perioperative period

  3. International normalized ratio (INR)

    Time frame: 7 days

    The levels of INR in perioperative period

  4. Albumin (ALB)

    Time frame: 7 days

    The levels of ALB in perioperative period

  5. Tumor necrosis factor-α (TNF-α)

    Time frame: 7 days

    The levels of TNF-α in perioperative period

  6. Malondialdehyde (MDA)

    Time frame: 7 days

    The levels of MDA in perioperative period

  7. Heme oxygenase-1 (HO-1)

    Time frame: 7 days

    The levels of HO-1 in perioperative period

  8. Nuclear Factor-κB (NF-κB)

    Time frame: 7 days

    The levels of NF-κB in perioperative period

  9. High mobility group box1 (HMGB1)

    Time frame: 7 days

    The levels of HMGB1 in perioperative period

  10. Platelet

    Time frame: 7 days

    The levels of platelet in perioperative period

  11. White blood cell (WBC)

    Time frame: 7 days

    The levels of WBC in perioperative period

  12. Neutrophil granulocyte percentage

    Time frame: 7 days

    The levels of neutrophil granulocyte percentage in perioperative period

  13. Time to gastrointestinal tolerance

    Time frame: 7 days

    Gastrointestinal tolerance was defined as transanal or stoma defecation and oral dietary tolerance.

  14. Prolonged postoperative ileus

    Time frame: 7 days

    Prolonged postoperative ileus was diagnosed if patients met two or more of the following conditions on or after postoperative day 4: inability to tolerate the oral diet over the past 24 h, nausea or vomiting, without flatus over the past 24 h, abdominal distension or radiological evidence of intestinal distension without mechanical intestinal obstruction.

  15. Rate of postoperative complications

    Time frame: 30 days

    The postoperative complications were recorded using the Clavien-Dindo classification system and included: nausea or vomiting, abdominal distension, anastomotic leakage, new pulmonary infection, poor wound healing, cognitive dysfunction, unplanned reoperation, and 30-day readmission rate.

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2023
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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