Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery

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Cholecystitis
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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