Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles
1 other identifier
observational
95
1 country
1
Brief Summary
The purpose of this study is to determine if extra systoles can be used to predict fluid responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft (CABG) surgery. As an additional study we will investigate the ability of a mini fluid challenge to predict response of a larger volume of fluid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2016
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
September 5, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 27, 2017
September 1, 2016
10 months
September 5, 2016
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cardiac output changes
From initiation of fluid infusion
At 5 minutes
Systolic arterial pressure changes
In relation to extra systoles
10 minutes prior to fluid infusion
Secondary Outcomes (1)
Arterial waveform changes
10 seconds
Study Arms (1)
Fluid Therapy
Systematisation of fluids during CABG surgery
Interventions
Eligibility Criteria
All patients scheduled for elective on pump CABG surgery at Aarhus University Hospital, SKS.
You may qualify if:
- Predominant sinus rhythm (No atrial fibrillation, trigemini, 2nd and 3rd degree atrioventricular block also if pacing is present etc.)
You may not qualify if:
- Ejection fraction \< 35% (Safety limit minimising risk of fluid overload)
- Haemodialysis (safety precaution for patients with end-stage kidney failure)
- Pregnancy
- Mentally retarded (due to lack of capability to sign an informed consent)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Department of Anesthesia and Intensive Care Medicine, Cardiothoracic Anesthesia, Head & Heart Centre, Aarhus University Hospital
Aarhus N, 8200, Denmark
Related Publications (1)
Berg JM, Nielsen DV, Abromaitiene V, Hjornet NE, Vistisen ST. Changes in arterial blood pressure characteristics following an extrasystolic beat or a fast 50 ml fluid challenge do not predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2022 Jun;36(3):889-900. doi: 10.1007/s10877-021-00722-z. Epub 2021 May 26.
PMID: 34041648DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2016
First Posted
September 16, 2016
Study Start
October 1, 2016
Primary Completion
August 1, 2017
Study Completion
October 1, 2017
Last Updated
October 27, 2017
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share
No consent for sharing personal data.