Perioperative Fluid Therapy Optimization in Spinal Surgery

Sponsor

University Hospital Hradec Kralove (Other)

Overall Status

Completed

CT.gov ID

NCT03644654

Collaborator

(none)

100

Enrollment

Location

Arms

23.3

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypovolemia Hypervolemia	Procedure: Standard care group Procedure: Noninvasive monitoring group	N/A

Detailed Description

The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Perioperative Fluid Therapy Optimization in Spinal Surgery Using Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards); a Comparison to Standard Method

Actual Study Start Date :

Aug 21, 2018

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard care group Fluid management will be done according standard care	Procedure: Standard care group 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).
Experimental: Noninvasive monitoring group Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards)	Procedure: Noninvasive monitoring group 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).

Arm

Intervention/Treatment

Active Comparator: Standard care group

Fluid management will be done according standard care

Procedure: Standard care group

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).

Experimental: Noninvasive monitoring group

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

Procedure: Noninvasive monitoring group

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).

Outcome Measures

Primary Outcome Measures

intraoperative fluid balance [5 hours]
the difference between fluid intake and output and losses during surgery

Secondary Outcome Measures

mean dose of norepinephrine [5 hours]
mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery
level of creatinine [24 hours]
plasma level of creatinine measured on the first postoperative day
pooperative lung dysfunction [24 hours]
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively
the length of postoperative stay [till 2 months after surgery]
the length of postoperative stay in hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Kralove		Czechia	50005

Sponsors and Collaborators

University Hospital Hradec Kralove

Investigators

Study Director: Pavel Dostal, MD, Ph.D., University Hospital Hradec Kralove

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dostalova Vlasta, MD, PhD, Principal Investigator, University Hospital Hradec Kralove

ClinicalTrials.gov Identifier:

NCT03644654

Other Study ID Numbers:

UHospital Hradec Kralove

First Posted:

Aug 23, 2018

Last Update Posted:

Nov 10, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dostalova Vlasta, MD, PhD, Principal Investigator, University Hospital Hradec Kralove

fluid responsiveness, haemodynamical monitoring, ClearSight

Additional relevant MeSH terms:

Hypovolemia

Study Results

No Results Posted as of Nov 10, 2020