Heart Failure and Hemodynamic Stability During Anesthesia Induction

Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Venous; Return (Anomaly); Hemodynamic Instability; Diastolic Dysfunction; Anesthesia; Adverse Effect
• Intervention / Treatment: Other: Preoperative colloid fluid bolus (Gelofusine); Diagnostic test: Preoperative transthoracic echocardiography

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Luleå, Sweden, 97180
    • Sunderby teaching hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of blood pressure drops	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 .	20 minutes post anesthesia induction
Incidence of severe blood pressure drops	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.	20 minutes post anesthesia induction

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Tomi Myrberg, MD PhD, Umeå Universitet

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 2, 2021

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (ACTUAL): July 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: anesthesia; heart failure; hemodynamics; venous return
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Plasma Substitutes; Blood Substitutes; Polygeline
• Other Study ID Numbers: 2016/361-31 III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No