Heart Failure and Hemodynamic Stability During Anesthesia Induction

Heart Failure Clinical Trial

Official title:

Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576261
• Other study ID #: 2016/361-31 III
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 2, 2021

Study information

• Verified date: December 2021
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Diastolic Dysfunction
• Heart Failure
• Hemodynamic Instability
• Venous; Return (Anomaly)

Intervention

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.

Locations

Country	Name	City	State
Sweden	Sunderby teaching hospital	Luleå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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