NCT02463175

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

May 29, 2015

Last Update Submit

October 24, 2017

Conditions

ScoliosisAcute Kidney Injury

Keywords

Fluid Therapy;Transesophageal Doppler

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Length of hospitalization

    30 days

  • Number of intra-operative hypotensive episodes

    During surgery

  • Percent case with intra-operative hypotension

    During surgery

  • Incidence of intra-operative spinal cord monitoring changes

    During surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Drug: PlasmalyteProcedure: Goal-directed fluid therapy (GDT)

Control group

EXPERIMENTAL

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

Drug: Plasmalyte

Interventions

PlasmalyteDRUG

Boluses of 5ml/kg of plasmalyte

Also known as: crystalloid solution for intravenous infusion
Control groupIntervention group
Goal-directed fluid therapy (GDT)PROCEDURE

Intraoperative goal-directed fluid therapy (GDT)

Intervention group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

ScoliosisAcute Kidney Injury

Interventions

Plasmalyte ACrystalloid SolutionsInfusions, Intravenous

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical PreparationsAdministration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

Study Officials

  • Zoe E Brown, MBChB, FRCA

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 4, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

CA(1)