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

A Randomized Controlled Pilot Study to Examine the Effects of Goal-directed Fluid Therapy on Post-operative Outcomes in Children Undergoing Scoliosis Repair

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.

Study Overview

• Status: Terminated
• Conditions: Scoliosis; Acute Kidney Injury
• Intervention / Treatment: Drug: Plasmalyte; Procedure: Goal-directed fluid therapy (GDT)

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • British Columbia Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Fluid management, boluses of 5ml/kg of plasmalyte, will follow a specific goal-directed fluid therapy (GDT) protocol guided by transesophageal doppler measurement	Drug: Plasmalyte; Boluses of 5ml/kg of plasmalyte; Other Names: crystalloid solution for intravenous infusion; Procedure: Goal-directed fluid therapy (GDT); Intraoperative goal-directed fluid therapy (GDT)
Experimental: Control group; Fluid management, using boluses of 5ml/kg of plasmalyte, will follow the current standard of care guided by clinical judgment	Drug: Plasmalyte; Boluses of 5ml/kg of plasmalyte; Other Names: crystalloid solution for intravenous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Zoe E Brown, MBChB, FRCA, University of British Columbia

Publications and helpful links

Helpful Links

• Pediatric Anesthesia Research Team website

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Fluid Therapy;; Transesophageal Doppler
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Acute Kidney Injury; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: H14-03098