ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 278399 for:    ALL

Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03594929
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:
Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.

Condition or disease Intervention/treatment Phase
Hepatocellular Cancer Device: Active RIC Device: Sham Control Not Applicable

Detailed Description:

Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.

50 patients with HCC undergoing partial hepatectomy will be randomised to receive either RIC (four-5 minute arm cuff inflations/deflations) or sham control (four-5 minute arm cuff simulated inflations/deflations) after induction of anesthesia and prior to surgical incision. The primary endpoint of the study will be acute liver injury assessed by serum transaminases measured at 24 hours post-resection. Secondary endpoints will include liver function in subset of patients (N=24, assessed by indocyanine green [ICG] clearance measured at 24 hours post-resection), incid ence of liver failure, episodes of confirmed sepsis, acute kidney injury, intensive care unit and hospital stay, and quality of life.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery: The ERIC-LIVER Trial
Actual Study Start Date : August 15, 2016
Estimated Primary Completion Date : January 18, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active RIC
Active RIC using a manual BP cuff to inflate to 200mmHg.
Device: Active RIC
Sham Comparator: Sham Control
A sham control using a manual blood pressure cuff visually identical to that used in the RIC protocol will be placed on the upper arm and a simulated RIC protocol will be administered.
Device: Sham Control



Primary Outcome Measures :
  1. serum ALT (unit/L) following liver resection, measured at 24 hours [ Time Frame: 24 hours ]
    serum ALT as a measure of acute liver injury

  2. serum AST (unit/L) following liver resection, measured at 24 hours [ Time Frame: 24 hours ]
    serum AST as a measure of acute liver injury


Secondary Outcome Measures :
  1. serum ALT (unit/L) following liver resection, measured at 6 hours [ Time Frame: 6 hours ]
    serum ALT as a measure of acute liver injury

  2. serum ALT (unit/L) following liver resection, measured at 48 hours [ Time Frame: 48 hours ]
    serum ALT as a measure of acute liver injury

  3. serum ALT (unit/L) following liver resection, measured at 2 weeks [ Time Frame: 2 weeks ]
    serum ALT as a measure of acute liver injury

  4. serum AST (unit/L) following liver resection, measured at 6 hours [ Time Frame: 6 hours ]
    serum AST as a measure of acute liver injury

  5. serum AST (unit/L) following liver resection, measured at 48 hours [ Time Frame: 48 hours ]
    serum AST as a measure of acute liver injury

  6. serum ALT (unit/L) following liver resection, measured at 2 weeks [ Time Frame: 2 weeks ]
    serum AST as a measure of acute liver injury

  7. Indocyanine Green (ICG) retention test. [ Time Frame: baseline in pre-admission clinic and post-operation day 1. ]
    Liver function as assessed by the ICG retention test. Testing is optional

  8. Acute liver ischemia reperfusion injury on histology [ Time Frame: up to 2 weeks ]
    Assessed by checking liver histology of the resected specimen

  9. presence/absence of liver failure based on serum bilirubin and INR on post op day 5 [ Time Frame: Baseline and day 5 post-surgery ]
    serum bilirubin and INR on post op day 5

  10. Episodes of culture-confirmed sepsis [ Time Frame: 30 days ]
    Episodes of culture-confirmed sepsis

  11. Serum creatine (umol/L) [ Time Frame: 3 days ]
    Measure of acute kidney injury based on rise in serum creatine on day 3 post op

  12. ITU and hospital stay [ Time Frame: Up to 30 days ]
    ITU and hospital stay

  13. Rate of hospital admission [ Time Frame: 30 days ]
    Rate of hospital admission

  14. Mortality [ Time Frame: 30 days ]
    Mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 21 years and above
  • Patients undergoing partial hepatectomy for primary HC

Exclusion Criteria:

  • Patients with significant pulmonary disease (FEV1<40% predicted).
  • Patients with known severe renal failure with a GFR<30 mL/min/1.73 m2.
  • Patients on sulphonylurea or nicorandil, as these medications may interfere with the protective effect of RIC.
  • Patients recruited into another study which may impact on this study. Significant peripheral arterial disease affecting the upper limbs.
  • Patients undergoing repeat liver resection surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594929


Contacts
Contact: Jin Yao Teo 63214515 teo.jin.yao@singhealth.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Jin Yao Teo    63214515    teo.jin.yao@singhealth.com.sg   
Sponsors and Collaborators
Singapore General Hospital
Duke-NUS Graduate Medical School

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03594929     History of Changes
Other Study ID Numbers: The ERIC-LIVER trial
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type