ScoliosisCardioQ-RPNCT02463175
Effects of Goal-directed Fluid Therapy on Post-operative Outcomes in Children Undergoing Scoliosis Repair
A study testing Plasmalyte and Goal-directed fluid therapy (GDT) in people with Scoliosis and Acute Kidney Injury, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Scoliosis, Acute Kidney Injury
- What is being tested?
- Plasmalyte and Goal-directed fluid therapy (GDT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing scoliosis repair
- ASA physical status classification system (ASA) I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
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
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.
Read the 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.
- Conditions
- Scoliosis, Acute Kidney Injury
- Being tested
- Plasmalyte, Goal-directed fluid therapy (GDT)
- Keywords
- Fluid Therapy;, Transesophageal Doppler
- Medical subject headings
- Scoliosis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmalyteDrug
Also called crystalloid solution for intravenous infusion
Boluses of 5ml/kg of plasmalyte
Goal-directed fluid therapy (GDT)Procedure or surgery
Intraoperative goal-directed fluid therapy (GDT)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Plasmalyte; Procedure: 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 Receives: Drug: Plasmalyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postsurgical kidney dysfunction
Serum creatinine; urine output; urine based interleukin 18 (IL-18) and neutrophil gelatinase-associated lipocalin (NGAL) biomarkers
Measured: Postop days 1-3
Secondary outcomes (4)
Length of hospitalization
Measured: 30 days
Number of intra-operative hypotensive episodes
Number of MAP decrease below 75% of baseline reading in pre-anesthesia clinic
Measured: During surgery
Percent case with intra-operative hypotension
Time spent hypotensive (MAP decrease below 75% of baseline reading) normalized by MAP measurement duration
Measured: During surgery
Incidence of intra-operative spinal cord monitoring changes
From the neurological monitoring [when available]: motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP)
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Difficulties with protocol compliance in both arms. Will simplify protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Görges, PhD, University of British Columbia
- Investigators
- Zoe E Brown, MBChB, FRCA, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463175
- Sponsor's protocol ID
- H14-03098
- Acronym
- CardioQ-RP
- Status last verified
- Oct 2017
- First submitted
- 29 May 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02463175
- Acronym / sponsor ID
- CardioQ-RP / H14-03098
- Conditions
- Scoliosis, Acute Kidney Injury
- Keywords
- Fluid Therapy;, Transesophageal Doppler
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with protocol compliance in both arms. Will simplify protocol.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Plasmalyte, Procedure: Goal-directed fluid therapy (GDT)Fluid management, boluses of 5ml/kg of plasmalyte, will follow a specific goal-directed fluid therapy (GDT) protocol guided by transesophageal doppler measurement |
| Control group | Experimental | Drug: PlasmalyteFluid management, using boluses of 5ml/kg of plasmalyte, will follow the current standard of care guided by clinical judgment |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients undergoing scoliosis repair
- ASA physical status classification system (ASA) I-III
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasmalyteAlso: crystalloid solution for intravenous infusionBoluses of 5ml/kg of plasmalyte | Drug | Control group, Intervention group |
| Goal-directed fluid therapy (GDT)Intraoperative goal-directed fluid therapy (GDT) | Procedure or surgery | Intervention group |
Primary outcome
Postsurgical kidney dysfunction
Time frame: Postop days 1-3
Serum creatinine; urine output; urine based interleukin 18 (IL-18) and neutrophil gelatinase-associated lipocalin (NGAL) biomarkers
4 secondary outcomes
Length of hospitalization
Time frame: 30 days
Number of intra-operative hypotensive episodes
Time frame: During surgery
Percent case with intra-operative hypotension
Time frame: During surgery
Incidence of intra-operative spinal cord monitoring changes
Time frame: During surgery
Results and safety
The study was stopped early (reason given: Difficulties with protocol compliance in both arms. Will simplify protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoe E Brown, MBChB, FRCA principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmalyte and Goal-directed fluid therapy (GDT) in people with Scoliosis and Acute Kidney Injury, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties with protocol compliance in both arms. Will simplify protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postsurgical kidney dysfunction (time frame: Postop days 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.