- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814239
Blood and Fluid Management During Scoliosis Surgery
Blood and Fluid Management During Scoliosis Surgery: A Single Center Retrospective Analysis
Study Overview
Detailed Description
At investigators institution, neither anesthetic approaches to replacement of blood or fluid losses were standardized before 2014 for scoliosis surgery. Before 2014, fluid therapy was liberal and according to general principles of good clinical practice and ephedrine boluses of 5 mg were given when fluid boluses failed to maintain a systolic arterial pressure >90 mm Hg. Blood was replaced with crystalloid at a 3:1 ratio and colloid at a 1:1 ratio. Regarding blood product transfusion anesthesiologists were generally initiated when hemoglobin levels were less than 8 g/dl or less than 10 g/dl in patients with coronary diseases and predonated autologous or allogeneic RBCs were administered.
A protocol of management for scoliosis surgery was implemented in 2014 and included: a) fluid therapy according to SVV monitor, b) intraoperative permissive hypotension to reduce active bleeding (goal mean arterial pressure 60 mmHg), c) prophylactic tranexamic acid infusion (30 mg/kg bolus, 1mg/kg/hr during surgery), d) restrictive RBC trigger according to national standardized protocols (Hb<7.0 g/dL or <9g/dL in patients with coronary diseases) and e) use of perioperative cell savage.
In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h right after general anesthesia induction and intubation. ClearSight System (Edwards Lifesciences Cop, Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously and noninvasively through finger- cuffed technology. If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%. After two consecutive fluid boluses SVV remained >15%, administration of noradrenaline infusion was considered.
Data will be collected from anesthesia records and included: age, gender, height, weight, body mass index and ASA score. Additional variables included infused crystalloid volume, infused colloid volume and the number of allogeneic transfused units of RBC. Serum Hb levels were measured preoperatively and after the end of surgery. Moreover, diuresis and use of vasopressors use were recorded.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Thessaloníki, Greece, 57010
- George Papanikoalou Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- severe curve (Cobb Angle > 70-degree)
- same surgeon in all procedures
Exclusion Criteria:
- Patients with coagulopathy,
- morbid obesity
- severe cardiopulmonary disease
- liver dysfunction
- renal disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
no protocol
liberal fluid therapy
|
|
protocol
fluid therapy according to stroke volume variation (SVV) monitor, tranexamic acid administration, use of cell saver
|
In patients of Group Protocol , basal crystalloid infusion was started at 4 ml/kg/h right after general anesthesia induction and intubation.
ClearSight System (Edwards Lifesciences Cop, Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously and noninvasively through finger- cuffed technology.
If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
After two consecutive fluid boluses SVV remained >15%, administration of noradrenaline infusion was considered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
units of red blood cells transfused
Time Frame: intraoperative
|
the overall units of red blood cells transfused during surgery.
Hb< 7 was the trigger for transfusion in protocol group and Hb<8 for no transfusion group.
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
volume of crystalloids infused
Time Frame: intraoperative
|
the overall volume of crystalloids infused during surgery.
In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
|
intraoperative
|
volume of colloids infused
Time Frame: intraoperative
|
the overall volume of colloid infused during surgery.
In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h.
If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
|
intraoperative
|
infused vasopressors
Time Frame: intraoperative
|
The decision to use ephedrine or noradrenaline.
In patients of Group Pro if after two consecutive fluid boluses SVV remained >15%, administration of noradrenaline or ephedrine was considered.
|
intraoperative
|
diuresis
Time Frame: intraoperative
|
volume of urine production during surgery.
|
intraoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Anastasia Trikoupi, Director of Anesthesiology Department
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- papskoliosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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