Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia
NCT ID: NCT03460938
Last Updated: 2019-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2017-03-08
2019-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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RIPC
Remote ischemic preconditioning
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.
Control
No interventions assigned to this group
Interventions
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Remote ischemic preconditioning
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.
Eligibility Criteria
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Inclusion Criteria
* Age \>18
Exclusion Criteria
18 Years
ALL
No
Sponsors
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St. Antonius Hospital
OTHER
Responsible Party
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dr. P. Noordzij
Principal Investigator
Principal Investigators
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Peter Noordzij, MD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
Locations
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St Antonius hospital
Nieuwegein, , Netherlands
Countries
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References
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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.
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.
Other Identifiers
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NL57818.100.16
Identifier Type: -
Identifier Source: org_study_id
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