FLuid Responsiveness Prediction Using EXtra Systoles

Coronary Artery Bypass Graft Clinical Trial

Official title:

FLuid Responsiveness Prediction Using EXtra Systoles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002129
• Other study ID #: FLEx study
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft

Intervention

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

Locations

Country	Name	City	State
Netherlands	Universitu Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid challenge response in stroke volume	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	during operation