Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery

Endothelial Dysfunction Clinical Trial

— PUMAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156711
• Other study ID #: REG-020-2019
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: September 14, 2021

Study information

• Verified date: September 2021
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute
• Endothelial Dysfunction

Intervention

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

Locations

Country	Name	City	State
Denmark	Center for Surgical Science, Surgical Department, Zealand University Hospital	Køge	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in endothelial function measured by reactive hyperemia index (RHI)	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	Heart rate variability	Changes in Heart rate variability measured with eMotion Faros from baseline and 24 hours consecutively.	24 hours
Secondary	Changes in p-L-arginine	Changes in p-L-arginine in µmol/L from baseline til 24h post-surgery	24 hours
Secondary	Changes in p-asymmetric dimethylarginine	Changes in p-asymmetric dimethylarginine in µmol/L from baseline til 24h post-surgery	24 hours
Secondary	Changes in p-biopterins	Changes in p-biopterins in ng/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in soluble endothelial (E-) selectin	Changes in soluble E-selectin in ng/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in soluble plasma (P-) selectin	Changes in soluble P-selectin in ng/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in Intercellular Adhesion Molecule 1 (ICAM-1)	Changes in soluble Intercellular Adhesion Molecule 1 (ICAM-1) in ng/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in syndecan-1	Changes in syndecan-1 in pg/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in thrombomodulin	Changes in thrombomodulin in pg/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in arginine vasopressin	Changes in arginine vasopressin in ng/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in adrenalin	Changes in adrenalin in ng/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in noradrenalin	Changes in noradrenalin in pg/ml from baseline til 24h post-surgery	24 hours
Secondary	Changes in ascorbic acid	Changes in ascorbic acid in ng/µL from baseline til 24h post-surgery	24 hours
Secondary	Changes in dehydroascorbic acid	Changes in dehydroascorbic acid in ng/µL from baseline til 24h post-surgery	24 hours
Secondary	Changes in angiotensin II	Changes in angiotensin II in pg/mL from baseline til 24h post-surgery	24 hours
Secondary	Changes in bradykinin	Changes in bradykinin in pg/mL from baseline til 24h post-surgery	24 hours
Secondary	Changes in calcitonin-gene related peptide	Changes in calcitonin-gene related peptide in pg/mL from baseline til 24h post-surgery	24 hours
Secondary	Changes in prostacyclin	Changes in prostacyclin in pg/mL from baseline til 24h post-surgery	24 hours
Secondary	Changes in serotonin	Changes in serotonin in ng/mL from baseline til 24h post-surgery	24 hours
Secondary	Changes in endothelin-1	Changes in endothelin-1 in pg/mL from baseline til 24h post-surgery	24 hours
Secondary	Changes in adrenomedullin	Changes in adrenomedullin in ng/mL from baseline til 24h post-surgery	24 hours
Secondary	Changes in platelets	Changes in platelets x 109/L from baseline til 24h post-surgery	24 hours
Secondary	Changes in adenosin	Changes in adenosin µmol/L from baseline til 24h post-surgery	24 hours
Secondary	Changes in interleukin-6(IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-alpha), transforming growth factor beta (TGF-beta)	Changes in IL-6, IL-10, TNF-Alpha, TGF-beta in pg/mL from baseline til 24h post-surgery	24 hours
Secondary	Changes in gene expression autoimmune human pathway panel from NanoString	Changes in gene expression profiles in the autoimmune human pathway panel from NanoString from baseline until four hours post-surgery.	4 hours
Secondary	Local complications to RIPC	Pain, changed sensibility or decreased function of the upper extremity where remote ischemic preconditioning were carried out preoperatively.	24 hours
Secondary	Differences in postoperative quality of recovery score 15 (QoR-15) between arms in the trial	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)	30 days
Secondary	Differences in Self reported pain on a 0-10 scale between arms in the trial	Self reported pain on a 0-10 scale at baseline and 24 hours after surgery between study arms (intervention and controls)	24 hours