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Heart Failure and Hemodynamic Stability During Anesthesia Induction

Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03576261
Enrollment
44
Registered
2018-07-03
Start date
2018-08-01
Completion date
2021-12-02
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

hemodynamics, venous return, heart failure, anesthesia

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.

Interventions

OTHERPreoperative colloid fluid bolus (Gelofusine)

Preoperative colloid fluid bolus

DIAGNOSTIC_TESTPreoperative 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.

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of blood pressure drops20 minutes post anesthesia inductionBlood 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 drops20 minutes post anesthesia inductionBlood 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

MeasureTime frameDescription
Venous return and hemodynamic stability20 minutes post anesthesia inductionLevel of venous return impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Systolic heart failure and hemodynamic stability20 minutes post anesthesia inductionSystolic heart failure impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Diastolic dysfunction and hemodynamic stability20 minutes post anesthesia inductionDiastolic dysfunction impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026