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

Primary Purpose

Scoliosis, Acute Kidney Injury

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Plasmalyte
Goal-directed fluid therapy (GDT)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Scoliosis focused on measuring Fluid Therapy;, Transesophageal Doppler

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • British Columbia Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention group

Control group

Arm Description

Fluid management, boluses of 5ml/kg of plasmalyte, will follow a specific goal-directed fluid therapy (GDT) protocol guided by transesophageal doppler measurement

Fluid management, using boluses of 5ml/kg of plasmalyte, will follow the current standard of care guided by clinical judgment

Outcomes

Primary Outcome Measures

Postsurgical kidney dysfunction
Serum creatinine; urine output; urine based interleukin 18 (IL-18) and neutrophil gelatinase-associated lipocalin (NGAL) biomarkers

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2015
Last Updated
October 24, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02463175
Brief Title
Effects of Goal-directed Fluid Therapy on Post-operative Outcomes in Children Undergoing Scoliosis Repair
Acronym
CardioQ-RP
Official Title
A Randomized Controlled Pilot Study to Examine the Effects of Goal-directed Fluid Therapy on Post-operative Outcomes in Children Undergoing Scoliosis Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulties with protocol compliance in both arms. Will simplify protocol.
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Written informed consent from parent/guardian and assent from the patient will be obtained. Each patient will be randomized into either the control arm or Cardio Q directed fluid therapy arm. 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 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). 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Acute Kidney Injury
Keywords
Fluid Therapy;, Transesophageal Doppler

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Fluid management, boluses of 5ml/kg of plasmalyte, will follow a specific goal-directed fluid therapy (GDT) protocol guided by transesophageal doppler measurement
Arm Title
Control group
Arm Type
Experimental
Arm Description
Fluid management, using boluses of 5ml/kg of plasmalyte, will follow the current standard of care guided by clinical judgment
Intervention Type
Drug
Intervention Name(s)
Plasmalyte
Other Intervention Name(s)
crystalloid solution for intravenous infusion
Intervention Description
Boluses of 5ml/kg of plasmalyte
Intervention Type
Procedure
Intervention Name(s)
Goal-directed fluid therapy (GDT)
Intervention Description
Intraoperative goal-directed fluid therapy (GDT)
Primary Outcome Measure Information:
Title
Postsurgical kidney dysfunction
Description
Serum creatinine; urine output; urine based interleukin 18 (IL-18) and neutrophil gelatinase-associated lipocalin (NGAL) biomarkers
Time Frame
Postop days 1-3
Secondary Outcome Measure Information:
Title
Length of hospitalization
Time Frame
30 days
Title
Number of intra-operative hypotensive episodes
Description
Number of MAP decrease below 75% of baseline reading in pre-anesthesia clinic
Time Frame
During surgery
Title
Percent case with intra-operative hypotension
Description
Time spent hypotensive (MAP decrease below 75% of baseline reading) normalized by MAP measurement duration
Time Frame
During surgery
Title
Incidence of intra-operative spinal cord monitoring changes
Description
From the neurological monitoring [when available]: motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP)
Time Frame
During surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoe E Brown, MBChB, FRCA
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.part.cfri.ca
Description
Pediatric Anesthesia Research Team website

Learn more about this trial

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

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