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Heart Failure and Hemodynamic Stability During Anesthesia Induction

U

Umeå University

Status

Completed

Conditions

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

Treatments

Diagnostic Test: Preoperative transthoracic echocardiography
Other: Preoperative colloid fluid bolus (Gelofusine)

Study type

Interventional

Funder types

Other

Identifiers

NCT03576261
2016/361-31 III

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Preoperative echo + fluids
Experimental group
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.
Treatment:
Other: Preoperative colloid fluid bolus (Gelofusine)
Diagnostic Test: Preoperative transthoracic echocardiography
Preoperative echo, control
Active Comparator group
Description:
20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction.
Treatment:
Diagnostic Test: Preoperative transthoracic echocardiography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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