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Heart Failure and Hemodynamic Stability During Anesthesia Induction

Primary Purpose

Hemodynamic Instability, Anesthesia; Adverse Effect, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Preoperative colloid fluid bolus (Gelofusine)
Preoperative transthoracic echocardiography
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemodynamic Instability focused on measuring hemodynamics, venous return, heart failure, anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sunderby teaching hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preoperative echo + fluids

Preoperative echo, control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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 .
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2018
Last Updated
December 15, 2021
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT03576261
Brief Title
Heart Failure and Hemodynamic Stability During Anesthesia Induction
Official Title
Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Instability, Anesthesia; Adverse Effect, Heart Failure, Diastolic Dysfunction, Venous; Return (Anomaly)
Keywords
hemodynamics, venous return, heart failure, anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preoperative echo + fluids
Arm Type
Experimental
Arm Description
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.
Arm Title
Preoperative echo, control
Arm Type
Active Comparator
Arm Description
20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction.
Intervention Type
Other
Intervention Name(s)
Preoperative colloid fluid bolus (Gelofusine)
Intervention Description
Preoperative colloid fluid bolus
Intervention Type
Diagnostic Test
Intervention Name(s)
Preoperative transthoracic echocardiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of blood pressure drops
Description
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 .
Time Frame
20 minutes post anesthesia induction
Title
Incidence of severe blood pressure drops
Description
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.
Time Frame
20 minutes post anesthesia induction
Secondary Outcome Measure Information:
Title
Venous return and hemodynamic stability
Description
Level of venous return impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Time Frame
20 minutes post anesthesia induction
Title
Systolic heart failure and hemodynamic stability
Description
Systolic heart failure impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Time Frame
20 minutes post anesthesia induction
Title
Diastolic dysfunction and hemodynamic stability
Description
Diastolic dysfunction impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Time Frame
20 minutes post anesthesia induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomi Myrberg, MD PhD
Organizational Affiliation
Umea Universitet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunderby teaching hospital
City
Luleå
ZIP/Postal Code
97180
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Heart Failure and Hemodynamic Stability During Anesthesia Induction

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