- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04156711
Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery (PUMAS)
Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery: The PUMAS Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zealand
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Køge, Zealand, Denmark, 4600
- Center for Surgical Science, Surgical Department, Zealand University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
Cycles of forearm ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability
Time Frame: 24 hours
|
Changes in Heart rate variability measured with eMotion Faros from baseline and 24 hours consecutively.
|
24 hours
|
Changes in p-L-arginine
Time Frame: 24 hours
|
Changes in p-L-arginine in μmol/L from baseline til 24h post-surgery
|
24 hours
|
Changes in p-asymmetric dimethylarginine
Time Frame: 24 hours
|
Changes in p-asymmetric dimethylarginine in μmol/L from baseline til 24h post-surgery
|
24 hours
|
Changes in p-biopterins
Time Frame: 24 hours
|
Changes in p-biopterins in ng/ml from baseline til 24h post-surgery
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24 hours
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Changes in soluble endothelial (E-) selectin
Time Frame: 24 hours
|
Changes in soluble E-selectin in ng/ml from baseline til 24h post-surgery
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24 hours
|
Changes in soluble plasma (P-) selectin
Time Frame: 24 hours
|
Changes in soluble P-selectin in ng/ml from baseline til 24h post-surgery
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24 hours
|
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
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24 hours
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Changes in syndecan-1
Time Frame: 24 hours
|
Changes in syndecan-1 in pg/ml from baseline til 24h post-surgery
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24 hours
|
Changes in thrombomodulin
Time Frame: 24 hours
|
Changes in thrombomodulin in pg/ml from baseline til 24h post-surgery
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24 hours
|
Changes in arginine vasopressin
Time Frame: 24 hours
|
Changes in arginine vasopressin in ng/ml from baseline til 24h post-surgery
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24 hours
|
Changes in adrenalin
Time Frame: 24 hours
|
Changes in adrenalin in ng/ml from baseline til 24h post-surgery
|
24 hours
|
Changes in noradrenalin
Time Frame: 24 hours
|
Changes in noradrenalin in pg/ml from baseline til 24h post-surgery
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24 hours
|
Changes in ascorbic acid
Time Frame: 24 hours
|
Changes in ascorbic acid in ng/μL from baseline til 24h post-surgery
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24 hours
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Changes in dehydroascorbic acid
Time Frame: 24 hours
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Changes in dehydroascorbic acid in ng/μL from baseline til 24h post-surgery
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24 hours
|
Changes in angiotensin II
Time Frame: 24 hours
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Changes in angiotensin II in pg/mL from baseline til 24h post-surgery
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24 hours
|
Changes in bradykinin
Time Frame: 24 hours
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Changes in bradykinin in pg/mL from baseline til 24h post-surgery
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24 hours
|
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
|
24 hours
|
Changes in prostacyclin
Time Frame: 24 hours
|
Changes in prostacyclin in pg/mL from baseline til 24h post-surgery
|
24 hours
|
Changes in serotonin
Time Frame: 24 hours
|
Changes in serotonin in ng/mL from baseline til 24h post-surgery
|
24 hours
|
Changes in endothelin-1
Time Frame: 24 hours
|
Changes in endothelin-1 in pg/mL from baseline til 24h post-surgery
|
24 hours
|
Changes in adrenomedullin
Time Frame: 24 hours
|
Changes in adrenomedullin in ng/mL from baseline til 24h post-surgery
|
24 hours
|
Changes in platelets
Time Frame: 24 hours
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Changes in platelets x 109/L from baseline til 24h post-surgery
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24 hours
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Changes in adenosin
Time Frame: 24 hours
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Changes in adenosin μmol/L from baseline til 24h post-surgery
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24 hours
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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
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Changes in IL-6, IL-10, TNF-Alpha, TGF-beta in pg/mL from baseline til 24h post-surgery
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24 hours
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Changes in gene expression autoimmune human pathway panel from NanoString
Time Frame: 4 hours
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Changes in gene expression profiles in the autoimmune human pathway panel from NanoString from baseline until four hours post-surgery.
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4 hours
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Local complications to RIPC
Time Frame: 24 hours
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Pain, changed sensibility or decreased function of the upper extremity where remote ischemic preconditioning were carried out preoperatively.
|
24 hours
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Differences in postoperative quality of recovery score 15 (QoR-15) between arms in the trial
Time Frame: 30 days
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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)
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30 days
|
Differences in Self reported pain on a 0-10 scale between arms in the trial
Time Frame: 24 hours
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Self reported pain on a 0-10 scale at baseline and 24 hours after surgery between study arms (intervention and controls)
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24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kirsten L Wahlstroem, MD, Center for Surgical Science, Zealand University Hospital,
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REG-020-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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