NCT04114799

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 invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Apr 2019Nov 2026

Study Start

First participant enrolled

April 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

6.1 years

First QC Date

September 7, 2019

Last Update Submit

May 9, 2024

Conditions

Brain Edema

Keywords

fluid responsivenesshaemodynamical monitoringClearSight

Outcome Measures

Primary Outcomes (1)

  • fluid balance difference

    the difference between fluid intake and output and losses during surgery will be calculated

    up to 5 hours after start of operation

Secondary Outcomes (4)

  • mean dose of norepinephrine

    up to 5 hours after start of operation

  • level of creatinin

    24 hours

  • postoperative lung dysfunction

    1 day

  • length of postoperative stay

    up to 2 month after surgery

Study Arms (2)

Group A invasive haemodynamical measurement

ACTIVE COMPARATOR

No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml/kg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml/kg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness.

Procedure: Hemodynamic management based on invasive fluid responsiveness parameters

Group B non-invasive haemodynamical measurement

EXPERIMENTAL

No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards).

Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement

Interventions

Hemodynamic management based on invasive fluid responsiveness parametersPROCEDURE

In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml/kg of Plasmalyte (Baxter)

Group A invasive haemodynamical measurement
Hemodynamic management based on noninvasive cardiac output and SVV measurementPROCEDURE

In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used.

Group B non-invasive haemodynamical measurement

Eligibility Criteria

Age18 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 surgery for brain tumor to 5 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

RECRUITING

MeSH Terms

Conditions

Brain Edema

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Pavel Dostal, MD, Ph.D.

    University Hospital Hradec Kralove

    STUDY DIRECTOR

Central Study Contacts

Vlasta Dostálová, MD, Ph.D.

CONTACT

777883571dostavla@seznam.cz

Pavel Dostal, MD, Ph.D.

CONTACT

+420495833218pavel.dostal@fnhk.cz

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

September 7, 2019

First Posted

October 3, 2019

Study Start

April 1, 2019

Primary Completion

April 30, 2025

Study Completion (Estimated)

November 30, 2026

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations

CZ(1)