---
title: Heart Failure and Hemodynamic Stability During Anesthesia Induction
nct_id: NCT03576261
overall_status: COMPLETED
phase: NA
sponsor: Umeå University
study_type: INTERVENTIONAL
primary_condition: Hemodynamic Instability
countries: Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03576261.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03576261"
ct_last_update_post_date: 2021-12-16
last_seen_at: "2026-05-12T07:03:06.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Heart Failure and Hemodynamic Stability During Anesthesia Induction

**Official Title:** Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction

**NCT ID:** [NCT03576261](https://clinicaltrials.gov/study/NCT03576261)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** Umeå University
- **Conditions:** Hemodynamic Instability, Anesthesia; Adverse Effect, Heart Failure, Diastolic Dysfunction, Venous; Return (Anomaly)
- **Start Date:** 2018-08-01
- **Completion Date:** 2021-12-02
- **CT.gov Last Update:** 2021-12-16

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **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.
- **Preoperative echo, control** (ACTIVE_COMPARATOR) — 20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction.

## Interventions

- **Preoperative colloid fluid bolus (Gelofusine)** (OTHER) — Preoperative colloid fluid bolus
- **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.

## Primary Outcomes

- **Incidence of blood pressure drops** _(time frame: 20 minutes post anesthesia induction)_ — 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** _(time frame: 20 minutes post anesthesia induction)_ — 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 Outcomes

- **Venous return and hemodynamic stability** _(time frame: 20 minutes post anesthesia induction)_
- **Systolic heart failure and hemodynamic stability** _(time frame: 20 minutes post anesthesia induction)_
- **Diastolic dysfunction and hemodynamic stability** _(time frame: 20 minutes post anesthesia induction)_

## Locations (1)

- Sunderby teaching hospital, Luleå, Sweden

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sunderby teaching hospital|luleå||sweden` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03576261.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03576261*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*