FLuid Responsiveness Prediction Using EXtra Systoles

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03002129
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Actual Duration (Months): 8
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.

Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass Graft	Other: fluid challenge	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: FLuid Responsiveness Prediction Using EXtra Systoles
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jun 26, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: fluid challenge	Other: fluid challenge; At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes

Outcome Measures

Primary Outcome Measures

1. fluid challenge response in stroke volume [during operation]

   To investigate if post-ectopic induced changes in blood pressure before a fluid bolus (5 ml/kg) predicts the fluid induced change in cardiac stroke volume

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients requiring elective CABG or OPCAB surgery

• Patient's age ≥ 18 years

Exclusion Criteria:

• Patient refusal

• Pregnancy

• EF < 35%

• End stage kidney failure (defined by the need for haemodialysis)

• Patients with atrial fibrillation or frequent and coupled extra systoles (e.g. trigemini)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitu Medical Center Groningen	Groningen		Netherlands	9713EZ

Sponsors and Collaborators

• University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof.dr.T.W.L.Scheeren, prof.dr., University Medical Center Groningen
• ClinicalTrials.gov Identifier: NCT03002129
• Other Study ID Numbers: FLEx study
• First Posted: Dec 23, 2016
• Last Update Posted: May 18, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Cardiac Complexes, Premature

Study Results

No Results Posted as of May 18, 2018