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Completed

NCT Number: NCT03644654

Perioperative Fluid Therapy Optimization in Spinal Surgery

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.

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Key information

Conditions

Hypovolemia Edema Hypervolemia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Care Group

Procedure

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

Procedure

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).

Primary outcomes

  1. intraoperative fluid balance

    Time frame: 5 hours

    the difference between fluid intake and output and losses during surgery

Secondary outcomes

  1. mean dose of norepinephrine

    Time frame: 5 hours

    mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery

  2. level of creatinine

    Time frame: 24 hours

    plasma level of creatinine measured on the first postoperative day

  3. pooperative lung dysfunction

    Time frame: 24 hours

    postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively

  4. the length of postoperative stay

    Time frame: till 2 months after surgery

    the length of postoperative stay in hospital

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 23, 2018
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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