NCT04156711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 23, 2019

Last Update Submit

September 23, 2021

Conditions

Acute CholecystitisEndothelial Dysfunction

Keywords

Remote ISchemic Preconditioning (RIPC)Acute surgeryAcute cholecystitisEndothelial dysfunctionHeart Rate Variability (HRV)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (28)

  • Heart rate variability

    24 hours

  • Changes in p-L-arginine

    24 hours

  • Changes in p-asymmetric dimethylarginine

    24 hours

  • Changes in p-biopterins

    24 hours

  • Changes in soluble endothelial (E-) selectin

    24 hours

  • +23 more secondary outcomes

Study Arms (2)

Remote Ischemic Preconditioning

EXPERIMENTAL

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)

Control

NO INTERVENTION

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)

Interventions

Remote Ischemic Preconditioning (RIPC)PROCEDURE

Cycles of forearm ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods

Remote Ischemic Preconditioning

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing acute or subacute cholecystectomy due to acute cholecystitis with a maximum of 7 days of symptoms prior to surgery

You may not qualify if:

  • Not capable of giving informed consent after oral and written information
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Surgical Science, Surgical Department, Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Kirsten L Wahlstroem, MD

    Center for Surgical Science, Zealand University Hospital,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Outcomes assessor are partly blinded and data analysis will be blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

November 7, 2019

Study Start

September 4, 2019

Primary Completion

September 14, 2021

Study Completion

September 14, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

DK(1)