Predicting Fluid Responsiveness in on Pump Coronary Arter... | NCT02903316

Studies
Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles

NCT02903316

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Oct 27, 2017Actual

Enrollment

95Actual

Phase

Not provided

Conditions

Hypovolemia
Coronary Artery Disease
Fluid Overload

Interventions

Fluids

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Aug 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Sep 5, 2016

First Submission Date that Met QC Criteria

Sep 12, 2016

First Posted Date

Sep 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2017

Last Update Posted Date

Oct 27, 2017Actual

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

From induction of anaesthesia to cardioplegia we will serve two fluid challenges. Before and after each challenge we will collect hemodynamic data and use this to asses our two hypotheses.

Fluid responsiveness (the outcome to predict) will be defined as a 15% increase in stroke volume(SV) from immediately before fluid infusion is initiated (baseline) to after the full fluid infusion. Stroke volume is derived from the gold-standard pulmonary artery catheter measurement of cardiac output(CO), which is standard monitoring for these patients (SV = CO/heart rate). From subsequent offline analysis of the extracted curve data we will investigate if post-ectopic characteristics from identified extra systoles during the baseline period can predict fluid responsiveness (i.e. the SV change). This analysis addresses the primary hypothesis. Also, we will analyse the arterial waveform related to the mini fluid challenge for morphologic changes (comparing heart beats before the infusion with heart beats during the infusion) and see if such transient changes, e.g. in systolic blood pressure, are able to predict fluid responsiveness. This analysis addresses the secondary hypothesis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluid Therapy		Systematisation of fluids during CABG surgery	Procedure: Fluids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluids	Procedure		Fluid Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Arterial waveform changes	From initiation of the mini fluid challenge (part of the compiled fluid challenge)	10 seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Predominant sinus rhythm (No atrial fibrillation, trigemini, 2nd and 3rd degree atrioventricular block also if pacing is present etc.)

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients scheduled for elective on pump CABG surgery at Aarhus University Hospital, SKS.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesia and Intensive Care Medicine, Cardiothoracic Anesthesia, Head & Heart Centre, Aarhus University Hospital		Aarhus N		8200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34041648	Derived	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.

ID	Term
D020896	Hypovolemia
D003324	Coronary Artery Disease
D004487	Edema

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003327	Coronary Disease
D017202	Myocardial Ischemia

ID	Term
D004358	Drug Therapy
D013812	Therapeutics