Clinical trial NCT04156711: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholecystitis
Endothelial Dysfunction
Keywords: Remote ISchemic Preconditioning (RIPC)
Acute surgery
Acute cholecystitis
Endothelial dysfunction
Heart Rate Variability (HRV)
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Changes in endothelial function measured by reactive hyperemia index (RHI)
timeFrame: 24 hours
Secondary outcomes:
measure: Heart rate variability
timeFrame: 24 hours
measure: Changes in p-L-arginine
timeFrame: 24 hours
measure: Changes in p-asymmetric dimethylarginine
timeFrame: 24 hours
measure: Changes in p-biopterins
timeFrame: 24 hours
measure: Changes in soluble endothelial (E-) selectin
timeFrame: 24 hours
measure: Changes in soluble plasma (P-) selectin
timeFrame: 24 hours
measure: Changes in Intercellular Adhesion Molecule 1 (ICAM-1)
timeFrame: 24 hours
measure: Changes in syndecan-1
timeFrame: 24 hours
measure: Changes in thrombomodulin
timeFrame: 24 hours
measure: Changes in arginine vasopressin
timeFrame: 24 hours
measure: Changes in adrenalin
timeFrame: 24 hours
measure: Changes in noradrenalin
timeFrame: 24 hours
measure: Changes in ascorbic acid
timeFrame: 24 hours
measure: Changes in dehydroascorbic acid
timeFrame: 24 hours
measure: Changes in angiotensin II
timeFrame: 24 hours
measure: Changes in bradykinin
timeFrame: 24 hours
measure: Changes in calcitonin-gene related peptide
timeFrame: 24 hours
measure: Changes in prostacyclin
timeFrame: 24 hours
measure: Changes in serotonin
timeFrame: 24 hours
measure: Changes in endothelin-1
timeFrame: 24 hours
measure: Changes in adrenomedullin
timeFrame: 24 hours
measure: Changes in platelets
timeFrame: 24 hours
measure: Changes in adenosin
timeFrame: 24 hours
measure: Changes in interleukin-6(IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-alpha), transforming growth factor beta (TGF-beta)
timeFrame: 24 hours
measure: Changes in gene expression autoimmune human pathway panel from NanoString
timeFrame: 4 hours
measure: Local complications to RIPC
timeFrame: 24 hours
measure: Differences in postoperative quality of recovery score 15 (QoR-15) between arms in the trial
timeFrame: 30 days
measure: Differences in Self reported pain on a 0-10 scale between arms in the trial
timeFrame: 24 hours
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Center for Surgical Science, Surgical Department, Zealand University Hospital
state: Zealand
Study officials:
affiliation: Center for Surgical Science, Zealand University Hospital,
name: Kirsten L Wahlstroem, MD
role: PRINCIPAL_INVESTIGATOR
References: