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Difficulties with protocol compliance in both arms. Will simplify protocol.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control group | Experimental | Fluid management, using boluses of 5ml/kg of plasmalyte, will follow the current standard of care guided by clinical judgment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmalyte | Drug | Boluses of 5ml/kg of plasmalyte |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postsurgical kidney dysfunction | Serum creatinine; urine output; urine based interleukin 18 (IL-18) and neutrophil gelatinase-associated lipocalin (NGAL) biomarkers | Postop days 1-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalization | 30 days | |
| Number of intra-operative hypotensive episodes | Number of MAP decrease below 75% of baseline reading in pre-anesthesia clinic | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoe E Brown, MBChB, FRCA | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
| D000077324 | Crystalloid Solutions |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D061605 | Administration, Intravenous |
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| Goal-directed fluid therapy (GDT) | Procedure | Intraoperative goal-directed fluid therapy (GDT) |
|
| Percent case with intra-operative hypotension | Time spent hypotensive (MAP decrease below 75% of baseline reading) normalized by MAP measurement duration | 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) | During surgery |
| D051437 |
| Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004333 |
| Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |