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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02463175
Acronym
CardioQ-RP
Enrollment
14
Registered
2015-06-04
Start date
2015-06-30
Completion date
2016-01-31
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis, Acute Kidney Injury

Keywords

Fluid Therapy;, Transesophageal Doppler

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.

Interventions

Boluses of 5ml/kg of plasmalyte

PROCEDUREGoal-directed fluid therapy (GDT)

Intraoperative goal-directed fluid therapy (GDT)

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postsurgical kidney dysfunctionPostop days 1-3Serum creatinine; urine output; urine based interleukin 18 (IL-18) and neutrophil gelatinase-associated lipocalin (NGAL) biomarkers

Secondary

MeasureTime frameDescription
Length of hospitalization30 days
Number of intra-operative hypotensive episodesDuring surgeryNumber of MAP decrease below 75% of baseline reading in pre-anesthesia clinic
Percent case with intra-operative hypotensionDuring surgeryTime spent hypotensive (MAP decrease below 75% of baseline reading) normalized by MAP measurement duration
Incidence of intra-operative spinal cord monitoring changesDuring surgeryFrom the neurological monitoring \[when available\]: motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026