Perioperative Fluid Therapy Optimization in Spinal Surgery

Hypovolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644654
• Other study ID #: UHospital Hradec Kralove
• Status: Completed
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: November 2022
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypervolemia
• Hypovolemia

Intervention

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).
• 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).

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

References & 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 (K — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative fluid balance	the difference between fluid intake and output and losses during surgery	5 hours
Secondary	mean dose of norepinephrine	mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery	5 hours
Secondary	level of creatinine	plasma level of creatinine measured on the first postoperative day	24 hours
Secondary	pooperative lung dysfunction	postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively	24 hours
Secondary	the length of postoperative stay	the length of postoperative stay in hospital	till 2 months after surgery