NCT03644654

Brief Summary

The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using continuous noninvasive cardiac output measurement with standard perioperative fluid management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

August 21, 2018

Last Update Submit

November 25, 2022

Conditions

HypovolemiaHypervolemia

Keywords

fluid responsiveness, haemodynamical monitoring, ClearSight

Outcome Measures

Primary Outcomes (1)

  • intraoperative fluid balance

    the difference between fluid intake and output and losses during surgery

    5 hours

Secondary Outcomes (4)

  • mean dose of norepinephrine

    5 hours

  • level of creatinine

    24 hours

  • pooperative lung dysfunction

    24 hours

  • the length of postoperative stay

    till 2 months after surgery

Study Arms (2)

Standard care group

ACTIVE COMPARATOR

Fluid management will be done according standard care

Procedure: Standard care group

Noninvasive monitoring group

EXPERIMENTAL

Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards)

Procedure: Noninvasive monitoring group

Interventions

Standard care groupPROCEDURE

Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. Fluid boluses will be used according to anesthesiologists decision (timing and amount of fluids). In case of drop of mean arterial pressure (MAP) below 65 mmHg norepinephrine will be started (with initial bolus of 5 - 10 ug).

Standard care group
Noninvasive monitoring groupPROCEDURE

Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. In case of hypotension (defined as a mean arterial pressure below 65 mmHg), the intervention will be led according to a protocol based on cardiac index, systemic vascular resitance and stroke volume variation (SVV) values (ClearSight, Edwards).

Noninvasive monitoring group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Glasgow Coma scale 15
  • ASA Physical Status Classification System I-III
  • planed spinal surgery to 3 hours
  • postoperative awakening
  • sinus rhythm

You may not qualify if:

  • NYHA III, IV
  • BMI over 40 in females and over 35 in men
  • awake operation
  • postoperative artificial ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Related Publications (1)

  • Kukralova L, Dostalova V, Cihlo M, Kraus J, Dostal P. The Impact of Individualized Hemodynamic Management on Intraoperative Fluid Balance and Hemodynamic Interventions during Spine Surgery in the Prone Position: A Prospective Randomized Trial. Medicina (Kaunas). 2022 Nov 20;58(11):1683. doi: 10.3390/medicina58111683.

    PMID: 36422222RESULT

MeSH Terms

Conditions

HypovolemiaEdema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Pavel Dostal, MD, Ph.D.

    University Hospital Hradec Kralove

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 23, 2018

Study Start

August 21, 2018

Primary Completion

April 30, 2020

Study Completion

July 30, 2020

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

CZ(1)