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Completed

NCT Number: NCT04156711

Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery

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.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Endothelial Dysfunction Gallbladder Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Surgical Science, Surgical Department, Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

remote ischemic preconditioning (RIPC)

Procedure

Cycles of forearm ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods

Primary outcomes

  1. Changes in endothelial function measured by reactive hyperemia index (RHI)

    Time frame: 24 hours

    Changes in endothelial function measured by reactive hyperemia index (RHI) at baseline, four hours and 24 hours after surgery (cholecystectomy due to acute cholecystitis)

Secondary outcomes

  1. Heart rate variability

    Time frame: 24 hours

    Changes in Heart rate variability measured with eMotion Faros from baseline and 24 hours consecutively.

  2. Changes in p-L-arginine

    Time frame: 24 hours

    Changes in p-L-arginine in μmol/L from baseline til 24h post-surgery

  3. Changes in p-asymmetric dimethylarginine

    Time frame: 24 hours

    Changes in p-asymmetric dimethylarginine in μmol/L from baseline til 24h post-surgery

  4. Changes in p-biopterins

    Time frame: 24 hours

    Changes in p-biopterins in ng/ml from baseline til 24h post-surgery

  5. Changes in soluble endothelial (E-) selectin

    Time frame: 24 hours

    Changes in soluble E-selectin in ng/ml from baseline til 24h post-surgery

  6. Changes in soluble plasma (P-) selectin

    Time frame: 24 hours

    Changes in soluble P-selectin in ng/ml from baseline til 24h post-surgery

  7. Changes in Intercellular Adhesion Molecule 1 (ICAM-1)

    Time frame: 24 hours

    Changes in soluble Intercellular Adhesion Molecule 1 (ICAM-1) in ng/ml from baseline til 24h post-surgery

  8. Changes in syndecan-1

    Time frame: 24 hours

    Changes in syndecan-1 in pg/ml from baseline til 24h post-surgery

  9. Changes in thrombomodulin

    Time frame: 24 hours

    Changes in thrombomodulin in pg/ml from baseline til 24h post-surgery

  10. Changes in arginine vasopressin

    Time frame: 24 hours

    Changes in arginine vasopressin in ng/ml from baseline til 24h post-surgery

  11. Changes in adrenalin

    Time frame: 24 hours

    Changes in adrenalin in ng/ml from baseline til 24h post-surgery

  12. Changes in noradrenalin

    Time frame: 24 hours

    Changes in noradrenalin in pg/ml from baseline til 24h post-surgery

  13. Changes in ascorbic acid

    Time frame: 24 hours

    Changes in ascorbic acid in ng/μL from baseline til 24h post-surgery

  14. Changes in dehydroascorbic acid

    Time frame: 24 hours

    Changes in dehydroascorbic acid in ng/μL from baseline til 24h post-surgery

  15. Changes in angiotensin II

    Time frame: 24 hours

    Changes in angiotensin II in pg/mL from baseline til 24h post-surgery

  16. Changes in bradykinin

    Time frame: 24 hours

    Changes in bradykinin in pg/mL from baseline til 24h post-surgery

  17. Changes in calcitonin-gene related peptide

    Time frame: 24 hours

    Changes in calcitonin-gene related peptide in pg/mL from baseline til 24h post-surgery

  18. Changes in prostacyclin

    Time frame: 24 hours

    Changes in prostacyclin in pg/mL from baseline til 24h post-surgery

  19. Changes in serotonin

    Time frame: 24 hours

    Changes in serotonin in ng/mL from baseline til 24h post-surgery

  20. Changes in endothelin-1

    Time frame: 24 hours

    Changes in endothelin-1 in pg/mL from baseline til 24h post-surgery

  21. Changes in adrenomedullin

    Time frame: 24 hours

    Changes in adrenomedullin in ng/mL from baseline til 24h post-surgery

  22. Changes in platelets

    Time frame: 24 hours

    Changes in platelets x 109/L from baseline til 24h post-surgery

  23. Changes in adenosin

    Time frame: 24 hours

    Changes in adenosin μmol/L from baseline til 24h post-surgery

  24. Changes in interleukin-6(IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-alpha), transforming growth factor beta (TGF-beta)

    Time frame: 24 hours

    Changes in IL-6, IL-10, TNF-Alpha, TGF-beta in pg/mL from baseline til 24h post-surgery

  25. Changes in gene expression autoimmune human pathway panel from NanoString

    Time frame: 4 hours

    Changes in gene expression profiles in the autoimmune human pathway panel from NanoString from baseline until four hours post-surgery.

  26. Local complications to RIPC

    Time frame: 24 hours

    Pain, changed sensibility or decreased function of the upper extremity where remote ischemic preconditioning were carried out preoperatively.

  27. Differences in postoperative quality of recovery score 15 (QoR-15) between arms in the trial

    Time frame: 30 days

    Questionnaire on Postoperative quality of recovery with 15 questions comparing scores from baseline, 24 hours and 30 days after surgery between study arms (intervention and controls)

  28. Differences in Self reported pain on a 0-10 scale between arms in the trial

    Time frame: 24 hours

    Self reported pain on a 0-10 scale at baseline and 24 hours after surgery between study arms (intervention and controls)

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery: The PUMAS Study

Acronym: PUMAS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2019
Registry last updated
Sep 29, 2021

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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