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Perioperative Fluid Therapy Optimization in Spinal Surgery

NCT03644654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-11-30

No results posted yet for this study

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.

Conditions

  • Hypovolemia
  • Hypervolemia

Interventions

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).

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).

Sponsors & Collaborators

  • University Hospital Hradec Kralove

    lead OTHER

Principal Investigators

  • Pavel Dostal, MD, Ph.D. · University Hospital Hradec Kralove

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-21
Primary Completion
2020-04-30
Completion
2020-07-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03644654 on ClinicalTrials.gov