Blood and Fluid Management During Scoliosis Surgery

February 6, 2019 updated by: Stachtari Chrysoula MD, PhD, George Papanicolaou Hospital

Blood and Fluid Management During Scoliosis Surgery: A Single Center Retrospective Analysis

In the present retrospective study, it was hypothesized that application, in scoliosis surgery, of a protocol for blood and fluid management, based on goal directed fluid therapy, cell salvage and tranexamic acid, could lead to reduced allogeneic red blood cells transfusion. The patients will be enrolled in a retrospective observational study and divided in two groups. Patients in no protocol Group received a liberal intraoperative fluid therapy and patients in protocol Group received fluid therapy managed according to a stroke volume variation based protocol. The protocol included fluid therapy according to SVV monitor, permissive hypotension, tranexamic acid infusion, restrictive RBC trigger and use of perioperative cell savage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Thessaloníki, Greece, 57010
        • George Papanikoalou Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective orthopaedic surgery of scoliosis, with a planned intensive care unit admission, were enrolled in a retrospective observational study.

Description

Inclusion Criteria:

  1. severe curve (Cobb Angle > 70-degree)
  2. same surgeon in all procedures

Exclusion Criteria:

  1. Patients with coagulopathy,
  2. morbid obesity
  3. severe cardiopulmonary disease
  4. liver dysfunction
  5. renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Anastasia Trikoupi, Director of Anesthesiology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2011

Primary Completion (Actual)

November 20, 2016

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 20, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • papskoliosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Scoliosis

Clinical Trials on protocol

3
Subscribe