Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery
- Conditions
- Acute CholecystitisEndothelial Dysfunction
- Interventions
- Procedure: Remote Ischemic Preconditioning (RIPC)
- Registration Number
- NCT04156711
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients undergoing acute or subacute cholecystectomy due to acute cholecystitis with a maximum of 7 days of symptoms prior to surgery
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remote Ischemic Preconditioning Remote Ischemic Preconditioning (RIPC) 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
- Primary Outcome Measures
Name Time Method Changes in endothelial function measured by reactive hyperemia index (RHI) 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
Name Time Method Changes in ascorbic acid 24 hours Changes in ascorbic acid in ng/μL from baseline til 24h post-surgery
Changes in angiotensin II 24 hours Changes in angiotensin II in pg/mL from baseline til 24h post-surgery
Changes in p-L-arginine 24 hours Changes in p-L-arginine in μmol/L from baseline til 24h post-surgery
Changes in soluble plasma (P-) selectin 24 hours Changes in soluble P-selectin in ng/ml from baseline til 24h post-surgery
Changes in calcitonin-gene related peptide 24 hours Changes in calcitonin-gene related peptide in pg/mL from baseline til 24h post-surgery
Changes in serotonin 24 hours Changes in serotonin in ng/mL from baseline til 24h post-surgery
Changes in endothelin-1 24 hours Changes in endothelin-1 in pg/mL from baseline til 24h post-surgery
Differences in Self reported pain on a 0-10 scale between arms in the trial 24 hours Self reported pain on a 0-10 scale at baseline and 24 hours after surgery between study arms (intervention and controls)
Changes in soluble endothelial (E-) selectin 24 hours Changes in soluble E-selectin in ng/ml from baseline til 24h post-surgery
Changes in syndecan-1 24 hours Changes in syndecan-1 in pg/ml from baseline til 24h post-surgery
Changes in dehydroascorbic acid 24 hours Changes in dehydroascorbic acid in ng/μL from baseline til 24h post-surgery
Changes in platelets 24 hours Changes in platelets x 109/L from baseline til 24h post-surgery
Changes in adenosin 24 hours Changes in adenosin μmol/L from baseline til 24h post-surgery
Changes in interleukin-6(IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-alpha), transforming growth factor beta (TGF-beta) 24 hours Changes in IL-6, IL-10, TNF-Alpha, TGF-beta in pg/mL from baseline til 24h post-surgery
Heart rate variability 24 hours Changes in Heart rate variability measured with eMotion Faros from baseline and 24 hours consecutively.
Changes in p-asymmetric dimethylarginine 24 hours Changes in p-asymmetric dimethylarginine in μmol/L from baseline til 24h post-surgery
Changes in Intercellular Adhesion Molecule 1 (ICAM-1) 24 hours Changes in soluble Intercellular Adhesion Molecule 1 (ICAM-1) in ng/ml from baseline til 24h post-surgery
Changes in thrombomodulin 24 hours Changes in thrombomodulin in pg/ml from baseline til 24h post-surgery
Changes in adrenalin 24 hours Changes in adrenalin in ng/ml from baseline til 24h post-surgery
Changes in noradrenalin 24 hours Changes in noradrenalin in pg/ml from baseline til 24h post-surgery
Changes in prostacyclin 24 hours Changes in prostacyclin in pg/mL from baseline til 24h post-surgery
Changes in adrenomedullin 24 hours Changes in adrenomedullin in ng/mL from baseline til 24h post-surgery
Differences in postoperative quality of recovery score 15 (QoR-15) between arms in the trial 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)
Changes in arginine vasopressin 24 hours Changes in arginine vasopressin in ng/ml from baseline til 24h post-surgery
Changes in gene expression autoimmune human pathway panel from NanoString 4 hours Changes in gene expression profiles in the autoimmune human pathway panel from NanoString from baseline until four hours post-surgery.
Local complications to RIPC 24 hours Pain, changed sensibility or decreased function of the upper extremity where remote ischemic preconditioning were carried out preoperatively.
Changes in p-biopterins 24 hours Changes in p-biopterins in ng/ml from baseline til 24h post-surgery
Changes in bradykinin 24 hours Changes in bradykinin in pg/mL from baseline til 24h post-surgery
Trial Locations
- Locations (1)
Center for Surgical Science, Surgical Department, Zealand University Hospital
🇩🇰Køge, Zealand, Denmark