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

Acute Kidney Injury Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02463175
• Other study ID #: H14-03098
• Status: Terminated
• Phase: N/A
• First received: May 29, 2015
• Last updated: October 24, 2017
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: October 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Scoliosis

Intervention

Drug:
• Plasmalyte
Boluses of 5ml/kg of plasmalyte

Procedure:
• Goal-directed fluid therapy (GDT)
Intraoperative goal-directed fluid therapy (GDT)

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of hospitalization		30 days
Secondary	Number of intra-operative hypotensive episodes	Number of MAP decrease below 75% of baseline reading in pre-anesthesia clinic	During surgery
Secondary	Percent case with intra-operative hypotension	Time spent hypotensive (MAP decrease below 75% of baseline reading) normalized by MAP measurement duration	During surgery
Secondary	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

External Links

•   Pediatric Anesthesia Research Team website