Brief Title
Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery
Official Title
Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery: The PUMAS Study
Brief Summary
This study examines if remote ischemic preconditioning in patients undergoing minor acute
abdominal surgery (laparoscopic cholecystitis due to acute cholecystitis) is associated with
a modulation of endothelial dysfunction. half of the patients will receive remote ischemic
preconditioning prior to surgery, the other half will serve as controls.
Detailed Description
Remote ischemic preconditioning (RIPC) consists of cycles of forearm or leg ischemia and
reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for
brief periods. The procedure is simple, safe and with no clear side effects. In clinical
studies covering acute cardiology RIPC has effectively reduced myocardial injury,
postoperative cardiovascular complications and cardiac mortality. Recently, the effect of
RIPC on attenuating ischemia-reperfusion injury has been investigated in non-cardiac surgery
as well. The organ specific ischemia-reperfusion injury, systemic oxidative stress and
inflammatory response were attenuated due to the intervention but a complete understanding of
the underlying protective mechanisms of RIPC is however still lacking.
Experimental and clinical studies have implicated that the stimulus of RIPC is transmitted
from the preconditioned tissue to other tissues and organs by humoral, neural and systemic
anti-inflammatory mediators. The humoral and neural pathway are thought to be dependent on
endogen substances such as adenosine, bradykinin, nitrogen oxide (NO) and
calcitonin-gene-related-peptide (CGRP).
Study Type
Interventional
Primary Outcome
Changes in endothelial function measured by reactive hyperemia index (RHI)
Secondary Outcome
Heart rate variability
Condition
Acute Cholecystitis
Intervention
Remote Ischemic Preconditioning (RIPC)
Study Arms / Comparison Groups
Remote Ischemic Preconditioning
Description: Remote ischemic preconditioning is carried out before the induction of general anesthesia. All four cycles will be completed before general anesthesia. The blood pressure cuff is placed on the upper limb. The cuff is inflated to 200 mmHg (if systolic blood pressures exceeds 185 mmHg, the cuff will be inflated to at least 15 mmHg above the systolic blood pressure) resulting in a total occlusion of the blood flow to the limb. After 5 minutes of ischemia, the cuff is deflated, and the limb is reperfused for 5 minutes. This cycle is repeated 4 times. Pulse oximetry is performed on the RIPC limb to make sure that the blood flow is completely interrupted during ischemia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
60
Start Date
September 4, 2019
Completion Date
June 30, 2021
Primary Completion Date
February 28, 2021
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing acute or subacute cholecystectomy due to acute cholecystitis with
a maximum of 7 days of symptoms prior to surgery
Exclusion Criteria:
- Not capable of giving informed consent after oral and written information
- Surgery within 30 days of study inclusion
- Conditions that prevent the performance of remote ischemic preconditioning on the
upper extremity, e.g. fractures, paresis, lymphedema
- performance of concomitant endoscopic retrograde cholangiopancreatography (ERCP)
during surgery
- synchronous pancreatitis
- synchronous cholangitis
Gender
All
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Kirsten L Wahlstroem, MD, +45 20 24 62 86, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04156711
Organization ID
REG-020-2019
Responsible Party
Sponsor
Study Sponsor
Zealand University Hospital
Study Sponsor
Kirsten L Wahlstroem, MD, Principal Investigator, Center for Surgical Science, Zealand University Hospital,
Verification Date
July 2020