NCT03460938

Brief Summary

High-risk abdominal surgery is frequently complicated by postoperative complications, such as sepsis, pneumonia or anastomotic dehiscence. Asymptomatic myocardial injury after abdominal surgery (MINS) predicts non-cardiac complications. The etiology of MINS in abdominal surgery patients is unknown. Remote ischemic preconditioning (RIPC) is a physiologic mechanism that exposes tissues to brief periods of non-lethal ischemia and reperfusion, creating resistence for future serious ischemic insults. RIPC in patients after cardiac or aortic surgery is associated with a protective effect on the heart. The effect of RIPC in abdominal surgery patients is unknown. Objective of the study: To determine the effect of RIPC on MINS in patients after pancreatic sugery. Study design: Randomised controlled parallel group mono-center pilot study. Study population: 90 adult patients scheduled for elective pancreaticoduodenectomy in St. Antonius Hospital (45 in the intervention group and 45 in the control group). Intervention: RIPC: 3 periods of 5 minutes of ischemia followed by 5 minutes of reperfusion are created by inflating a blood pressure cuff on the upper extremity after induction of anesthesia and prior to surgery. In the control group a non-inflated blood pressure cuff is placed on the upper extremity for 30 minutes. Primary study parameters/outcome of the study: Maximum postoperative concentration of high-sensitive cardiac troponin T. Secondary study parameters/outcome of the study: Markers of inflammatory, intestinal and renal injury, postoperative complications during 30 days, length of stay and hospital mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

March 29, 2017

Last Update Submit

April 22, 2019

Conditions

Myocardial IschemiaInflammatory Response

Outcome Measures

Primary Outcomes (1)

  • Postoperative myocardial injury.

    Maximum postoperative concentration of high-sensitive cardiac troponin T.

    48 hours

Secondary Outcomes (2)

  • Inflammatory response

    48 hours

  • Postoperative complications

    30 days

Study Arms (2)

RIPC

EXPERIMENTAL
Procedure: Remote ischemic preconditioning

Control

NO INTERVENTION

Interventions

Remote ischemic preconditioningPROCEDURE

RIPC: 3 periods of 5 minutes of ischemia followed by 5 minutes of reperfusion are created by inflating a blood pressure cuff on the upper extremity after induction of anesthesia and prior to surgery.

RIPC

Eligibility Criteria

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

You may qualify if:

  • Elective pancreaticoduodenectomy
  • Age \>18

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius hospital

Nieuwegein, Netherlands

Location

Related Publications (2)

  • Reniers T, Rettig T, van Zeggeren L, Dijkstra I, Prinsze K, Molenaar I, van Santvoort H, Cremer O, Vernooij L, Noordzij P. Is chronic inflammation a risk factor for perioperative myocardial injury or heart failure in pancreatic surgery patients? BJA Open. 2025 May 19;14:100417. doi: 10.1016/j.bjao.2025.100417. eCollection 2025 Jun.

    PMID: 40491666DERIVED

  • van Zeggeren L, Visser RA, Vernooij LM, Dijkstra IM, Bosma M, Molenaar Q, van Santvoort HC, Noordzij PG. The effect of remote ischaemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial. BJS Open. 2021 Mar 5;5(2):zrab015. doi: 10.1093/bjsopen/zrab015.

    PMID: 33893738DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Peter Noordzij, MD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2017

First Posted

March 9, 2018

Study Start

March 8, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)