Heart Failure and Hemodynamic Stability During Anesthesia Induction

NCT03576261 | Completed

• 1 other identifier: 2016/361-31 III
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

hemodynamics; venous return; heart failure; anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Venous return and hemodynamic stability

  20 minutes post anesthesia induction

• Systolic heart failure and hemodynamic stability

  20 minutes post anesthesia induction

• Diastolic dysfunction and hemodynamic stability

  20 minutes post anesthesia induction

Study Arms (2)

Preoperative echo + fluids

EXPERIMENTAL

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); Diagnostic Test: Preoperative transthoracic echocardiography

Preoperative echo, control

ACTIVE COMPARATOR

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

Diagnostic Test: Preoperative transthoracic echocardiography

Interventions

Preoperative colloid fluid bolus (Gelofusine) OTHER

Preoperative colloid fluid bolus

Preoperative echo + fluids

Preoperative transthoracic echocardiography DIAGNOSTIC_TEST

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.

Preoperative echo + fluids; Preoperative echo, control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• body mass index ≤ 35 kg/m2
• electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery

You may not qualify if:

• instable angina pectoris
• severe bronchial asthma
• severe COPD
• dementia
• severe heart valve disease
• severe renal failure
• body mass index \> 35 kg/m2

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Sunderby teaching hospital

Luleå, 97180, Sweden

Location

MeSH Terms

Conditions

Heart Failure; Congenital Abnormalities

Interventions

Polygeline

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Polymers; Macromolecular Substances; Peptides; Amino Acids, Peptides, and Proteins; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Tomi Myrberg, MD PhD

  Umea Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 3, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 2, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)