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Perioperative Reduction of Inapparent Myocardial Injury (PRIME)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Royal Berkshire NHS Foundation Trust
Information provided by (Responsible Party):
London Surgical Research Group
ClinicalTrials.gov Identifier:
NCT01850927
First received: May 7, 2013
Last updated: March 5, 2016
Last verified: March 2016
  Purpose

Recent data suggests that subclinical myocardial injury occurs in patients undergoing major abdominal surgery, and the degree of damage is proportionally linked to morbidity and mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage are urgently needed.

Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion stimulus gives a protective effect to further ischemic insults. In remote ischemic preconditioning (RIPC), this initial stimulus is carried out away from the region of interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing cardiac damage during bypass grafting, as characterised by troponin release, seems to be about 35%.

The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in patients undergoing major abdominal surgery. Post-operative troponin release will be used as a surrogate marker of myocardial damage. There is no good data on which to build a reliable sample size calculation, therefore we estimated samples sizes using supplementary data from the recent VISION study. The investigators intend to build a clinically powered study from the results of this study.

Study design will be by single-centre single-blind randomised control trial. Allocation will be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5 minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for the same amount of time.

Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse cardiovascular events, serious surgical complications, non-cardiovascular death, quality of life, and length of stay.


Condition Intervention
Perioperative Myocardial Injury
Procedure: Remote ischaemic preconditioning
Procedure: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial

Further study details as provided by London Surgical Research Group:

Primary Outcome Measures:
  • Peak post-operative troponin (ng/L) [ Time Frame: At 6-12, 24, 48, 72h ]

Secondary Outcome Measures:
  • Any major adverse cardiovascular events [ Time Frame: 30 days ]
    "MACCE" - defined as any new arrhythmia, myocardial infarction, congestive heart failure, angina, stroke or non-fatal cardiac arrest, or cerebrovascular or cardiovascular death

  • Any serious surgical complications [ Time Frame: 30 days ]
    'SSG' - defined as any post-operative complication requiring radiological, surgical, or endoscopic intervention, or intensive care, or leading to non-vascular death (i.e. Calvien-Dindo III-V).

  • Area-under-the-curve post-operative troponin (ng/L) [ Time Frame: 72 hours ]
  • Positive post-operative troponin (binary endpoint, >20ng/L) [ Time Frame: 72 hours ]

Enrollment: 84
Study Start Date: June 2013
Estimated Study Completion Date: March 2017
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
Patients will receive remote ischaemic preconditioning prior to surgery. After the induction of anaesthesia, a blood pressure cuff will be placed on an upper arm and inflated to 200mmHg for 5 minutes, then deflated for 5 minutes, repeated for a total of 3 inflation-deflation cycles.
Procedure: Remote ischaemic preconditioning
Sham Comparator: Control
Patients will have the same procedure as for the intervention group, however the blood pressure cuff valve will be left open throughout the 30 minute treatment. Patients will be kept under anaesthesia for this additional time.
Procedure: Control

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • is ≥ 45 years old;
  • is undergoing elective major colorectal or upper GI surgery.

Exclusion Criteria

  • Diabetic patients that are taking glibenclamide medication
  • Patients with upper limb peripheral vascular disease, including those with arteriovenous fistula for dialysis
  • Untreated hypertension (defined as two or more readings >180mmHg systolic on admission for surgery)
  • Current participation in any study investigating troponin levels or ischaemic preconditioning
  • Unable or lacks capacity to give informed consent to participation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850927

Locations
United Kingdom
Royal Berkshire Hospital
Reading, Berks, United Kingdom, RM7 0AG
Sponsors and Collaborators
London Surgical Research Group
Royal Berkshire NHS Foundation Trust
Investigators
Study Director: Andrew Walden, MBBS PhD MRCP Royal Berkshire Hospitals
Principal Investigator: Stefan S Antonowicz, MBChB MRCS Royal berkshire Hospitals
  More Information

Responsible Party: London Surgical Research Group
ClinicalTrials.gov Identifier: NCT01850927     History of Changes
Other Study ID Numbers: LSRG-002
Study First Received: May 7, 2013
Last Updated: March 5, 2016

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on March 24, 2017