Heart Failure and Hemodynamic Stability During Anesthesia Induction

Sponsor

Umeå University (Other)

Overall Status

Completed

CT.gov ID

NCT03576261

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (TCI) in non-cardiac, non-morbidly obese surgery.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability Anesthesia; Adverse Effect Heart Failure Diastolic Dysfunction Venous; Return (Anomaly)	Other: Preoperative colloid fluid bolus (Gelofusine) Diagnostic Test: Preoperative transthoracic echocardiography	N/A

Detailed Description

40 individuals are enrolled to the study after signed informed consent at the day of surgery. The study participants are randomized (non-blinded) to preoperative fluid therapy (preoperative colloid fluid bolus at 6 ml/kg LBW, Gelofusine™, Fresenius Kabi AB, Sweden) or control (no preoperative fluids) before standardized TCI- induction of anesthesia. No other intravenous fluids before anesthesia induction.

Preoperative screening of biventricular systolic and diastolic function of the heart and level of venous return is implemented by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A consecutive cohort. Signed informed consent is gathered. Non-blinded randomization is conducted to fluid therapy before anesthesia induction. Preoperative diagnostics by echocardiography is conducted to all participants.Two arms, with or without preoperative fluids, are studied regarding hemodynamic stability during anesthesia induction.A consecutive cohort. Signed informed consent is gathered. Non-blinded randomization is conducted to fluid therapy before anesthesia induction. Preoperative diagnostics by echocardiography is conducted to all participants.Two arms, with or without preoperative fluids, are studied regarding hemodynamic stability during anesthesia induction.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Preoperative echo + fluids 20 individuals investigated by preoperative transthoracic echocardiography. Preoperative colloid fluid bolus (Gelofusine, Fresenius Kabi AB, Sweden) 6 ml/kg lean body weight, is infused intravenously immediately before anesthesia induction.	Other: Preoperative colloid fluid bolus (Gelofusine) Preoperative colloid fluid bolus Diagnostic Test: Preoperative transthoracic echocardiography Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.
Active Comparator: Preoperative echo, control 20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction.	Diagnostic Test: Preoperative transthoracic echocardiography Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Arm

Intervention/Treatment

Experimental: Preoperative echo + fluids

20 individuals investigated by preoperative transthoracic echocardiography. Preoperative colloid fluid bolus (Gelofusine, Fresenius Kabi AB, Sweden) 6 ml/kg lean body weight, is infused intravenously immediately before anesthesia induction.

Other: Preoperative colloid fluid bolus (Gelofusine)

Preoperative colloid fluid bolus

Diagnostic Test: Preoperative transthoracic echocardiography

Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.

Active Comparator: Preoperative echo, control

20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction.

Diagnostic Test: Preoperative transthoracic echocardiography

Outcome Measures

Primary Outcome Measures

Incidence of blood pressure drops [20 minutes post anesthesia induction]
Blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction .
Incidence of severe blood pressure drops [20 minutes post anesthesia induction]
Blood pressure drop below mean arterial pressure at 55 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction.

Secondary Outcome Measures

Venous return and hemodynamic stability [20 minutes post anesthesia induction]
Level of venous return impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Systolic heart failure and hemodynamic stability [20 minutes post anesthesia induction]
Systolic heart failure impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Diastolic dysfunction and hemodynamic stability [20 minutes post anesthesia induction]
Diastolic dysfunction impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age over 18 years
body mass index ≤ 35 kg/m2
electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery

Exclusion Criteria:

instable angina pectoris
severe bronchial asthma
severe COPD
dementia
severe heart valve disease
severe renal failure
body mass index > 35 kg/m2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunderby teaching hospital	Luleå		Sweden	97180

Sponsors and Collaborators

Umeå University

Investigators

Principal Investigator: Tomi Myrberg, MD PhD, Umea Universitet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tomi Myrberg, Principal investigator, Umeå University

ClinicalTrials.gov Identifier:

NCT03576261

Other Study ID Numbers:

2016/361-31 III

First Posted:

Jul 3, 2018

Last Update Posted:

Dec 16, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tomi Myrberg, Principal investigator, Umeå University

Additional relevant MeSH terms:

Heart Failure

Polygeline

Study Results

No Results Posted as of Dec 16, 2021