Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery (PUMAS)

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: NCT04156711
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Cholecystitis Endothelial Dysfunction Procedure: Remote Ischemic Preconditioning (RIPC) Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Outcomes assessor are partly blinded and data analysis will be blinded
Primary Purpose: Prevention
Official Title: Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery: The PUMAS Study
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remote Ischemic Preconditioning
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
Procedure: Remote Ischemic Preconditioning (RIPC)
Cycles of forearm ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods

No Intervention: Control
Will receive no intervention, but will go through same tests at the same time-points (endothelial function measured by reactive hyperemia index, blood samples, Heart rate variability and questionaires)



Primary Outcome Measures :
  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 Outcome Measures :
  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 metabolic pathway panel from NanoString [ Time Frame: 4 hours ]
    Changes in gene expression profiles in the metabolic pathway panel from NanoString from baseline until four hours post-surgery.

  26. Differences in mesenterial vessel contractility between arms in the trial [ Time Frame: 6 hours ]
    Using wire myographs with isolated mesenterial vessels to measure contractility following drug administration of adrenalin and adrenomedullin in patients from both arms (intervention and controls)

  27. 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.

  28. 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)

  29. 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)



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04156711


Contacts
Layout table for location contacts
Contact: Kirsten L Wahlstroem, MD +45 20 24 62 86 kirstenwahlstroem@gmail.com

Locations
Layout table for location information
Denmark
Center for Surgical Science, Surgical Department, Zealand University Hospital Recruiting
Køge, Zealand, Denmark, 4600
Contact: Kirsten L Wahlstroem, MD    +45 20 24 62 86    kirstenwahlstroem@gmail.com   
Sponsors and Collaborators
Zealand University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Kirsten L Wahlstroem, MD Center for Surgical Science, Zealand University Hospital,

Layout table for additonal information
Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04156711     History of Changes
Other Study ID Numbers: REG-020-2019
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
Remote ISchemic Preconditioning (RIPC)
Acute surgery
Acute cholecystitis
Endothelial dysfunction
Heart Rate Variability (HRV)
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases