Effects of Goal-directed Fluid Therapy on Post-operative Outcomes in Children Undergoing Scoliosis Repair

Not Applicable

Terminated

• Conditions: Scoliosis; Acute Kidney Injury
• Interventions: Drug: Plasmalyte; Procedure: Goal-directed fluid therapy (GDT)

• Registration Number: NCT02463175
• Lead Sponsor: University of British Columbia

Brief Summary

Surgery for scoliosis correction, the abnormal curvature of the spine, is a major procedure often undertaken in adolescents. In adult anesthesia, there is a large volume of literature debating how to optimize fluids administered during surgery, as both too much fluid and too little fluid are associated with worse outcomes. The investigators will compare fluid administration based on the measured amount of blood pumped by the heart during each heart beat (goal-directed therapy), against standard anesthetic management. The main outcomes are a) post-surgical kidney dysfunction, b) prevalence of intraoperative hypotension, c) volumes of administered fluids, and d) length of hospitalization.

Detailed Description

1. Written informed consent from parent/guardian and assent from the patient will be obtained.

2. Each patient will be randomized into either the control arm or Cardio Q directed fluid therapy arm.

3. The following standard monitors will be placed before induction of anesthesia: electrocardiography, non-invasive blood pressure and pulse oximetry. The patient is anesthetized in the supine position using a standardized anesthetic technique. All attempts will be made to maintain normothermia

4. Following induction of anesthesia, the following will be placed: invasive arterial cannula, large bore intravenous cannula, Bispectral index monitor, temperature probe and central venous cannula (if needed).

5. Cardiac output monitor: Following induction of anesthesia and after placement of appropriate lines and monitors, a transoesophageal doppler (TED) probe will be inserted through the mouth into the esophagus and positioned correctly. A normal saline infusion will be started once the patient is anesthetized at 0.5 ml/kg/hour in the line where the drugs will be infused.

1. Control Group: In this group, fluid administration, using boluses of 5ml/kg of plasmalyte at the anesthesiologist's discretion will be used. Anesthesiologists will be blinded to the cardio-Q numerics on the monitor. The flow waveform and sound will be available to optimize probe position.

2. Intervention groups: Boluses of 5ml/kg plasmalyte will be given when: either MAP drops 20% from baseline or stroke volume drops 15% from baseline. If the patient is fluid responsive, a further 5ml/kg of fluid will be given.

3. Vasopressor use: MAP (and stroke volume) becomes unresponsive to a fluid bolus then a bolus of phenylephrine or ephedrine may be given at the anesthesiologist's discretion.

Study Timeline

• Study First Submitted: 2015-05-29
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-04
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patients undergoing scoliosis repair
• ASA physical status classification system (ASA) I-III

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Exclusion Criteria

• Pre-existing chronic kidney disease
• Oropharyngeal disease, e.g. pharyngitis
• Esophageal disease, e.g. heartburn, esophageal varices or hiatus hernia.
• Coagulopathy
• Scheduled for two stage procedures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Goal-directed fluid therapy (GDT)	Fluid management, boluses of 5ml/kg of plasmalyte, will follow a specific goal-directed fluid therapy (GDT) protocol guided by transesophageal doppler measurement
Control group	Plasmalyte	Fluid management, using boluses of 5ml/kg of plasmalyte, will follow the current standard of care guided by clinical judgment
Intervention group	Plasmalyte	Fluid management, boluses of 5ml/kg of plasmalyte, will follow a specific goal-directed fluid therapy (GDT) protocol guided by transesophageal doppler measurement

Primary Outcome Measures

Name	Time	Method
Postsurgical kidney dysfunction	Postop days 1-3	Serum creatinine; urine output; urine based interleukin 18 (IL-18) and neutrophil gelatinase-associated lipocalin (NGAL) biomarkers

Secondary Outcome Measures

Name	Time	Method
Length of hospitalization	30 days
Number of intra-operative hypotensive episodes	During surgery	Number of MAP decrease below 75% of baseline reading in pre-anesthesia clinic
Percent case with intra-operative hypotension	During surgery	Time spent hypotensive (MAP decrease below 75% of baseline reading) normalized by MAP measurement duration
Incidence of intra-operative spinal cord monitoring changes	During surgery	From the neurological monitoring \[when available\]: motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP)

Trial Locations

Locations (1)

British Columbia Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada