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

NCT ID: NCT02463175

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Scoliosis; Acute Kidney Injury

Keywords

Fluid Therapy; Transesophageal Doppler

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Plasmalyte

Intervention Type: DRUG

Boluses of 5ml/kg of plasmalyte

Goal-directed fluid therapy (GDT)

Intervention Type: PROCEDURE

Intraoperative goal-directed fluid therapy (GDT)

Control group

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

Group Type: EXPERIMENTAL

Plasmalyte

Intervention Type: DRUG

Boluses of 5ml/kg of plasmalyte

Interventions

Plasmalyte

Boluses of 5ml/kg of plasmalyte

Intervention Type: DRUG

Goal-directed fluid therapy (GDT)

Intraoperative goal-directed fluid therapy (GDT)

Intervention Type: PROCEDURE

Other Intervention Names

crystalloid solution for intravenous infusion

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Matthias Görges, PhD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zoe E Brown, MBChB, FRCA

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Related Links

http://www.part.cfri.ca

Pediatric Anesthesia Research Team website

Other Identifiers

H14-03098

Identifier Type: -

Identifier Source: org_study_id