Fluid Optimization With Crystalloids and Colloids in Neurosurgery (KOKR)
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Sterofundin (Bolus of crystalloids)
Voluven (Bolus of colloids)
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications
Eligibility Criteria
Inclusion Criteria:
- neurosurgery (tumour, vascular, adenoma), haemodynamic stability
Exclusion Criteria:
- arrhythmia
Sites / Locations
- University Medical Centre Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Crystalloids
Colloids
Arm Description
Bolus of crystalloids Bolus of 250 ml crystaloids will be infused regarding the measures
Bolus of colloids Bolus of 250 ml colloids will be infused regarding the measures
Outcomes
Primary Outcome Measures
Consumption of optimisation fluid
Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid
Secondary Outcome Measures
Postoperative complications
The investigators will record the incidence of postoperative complications Complications in different organs will be recorded (nevrological, pulmological, cardiovascular, haematological, infection, wound). The investigator will evaluate the days in the hospital after the surgery and the mortality rate (the number of deaths) for the 15 days after the surgery or until death or the dissmision.
Full Information
NCT ID
NCT03249298
First Posted
April 7, 2017
Last Updated
September 14, 2021
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT03249298
Brief Title
Fluid Optimization With Crystalloids and Colloids in Neurosurgery
Acronym
KOKR
Official Title
Comparison of Crystaloids and Colloids for Fluid Optimization in Patients Undergoing Neurosurgical Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
5. Study Description
Brief Summary
Fluid optimization in neurosurgical patients has an important impact on preservation of cerebral perfusion pressure and minimization of cerebral oedema during and after the craniotomy. The investigators would like to know if crystalloids or colloids are equally useful for goal directed therapy in this patients. The investigators will record haemodynamic stability, volume loading and postoperative complications and compare two groups of patients. One group will be optimised with crystalloids and the second with colloids. The investigators will compare also hospital stay and mortality in the two groups.
Detailed Description
Hemodynamic stability and maintenance of cerebral perfusion pressure (CPP) are important in neurosurgical patients. Fluid management includes maintenance of intravascular volume, preservation of cerebral perfusion pressure and minimization of cerebral oedema. Fluid management of the neurosurgical patient has advanced from "run them dry" to "run them isovolaemic, isotonic and iso-oncotic, but the induction of potential complications by current strategies are still unknown. Advanced techniques provide goal directed fluid therapy which is currently the gold standard in fluid strategy. In patients undergoing craniotomy diuretics, preoperative fasting, induction of general anaesthesia and intraoperative bleeding may lead to hypovolemia and poor cerebral perfusion. On the other hand fluid overload increases complications and hospital stay after surgery. It is, therefore, important that optimal fluid levels are achieved.
The aim of the study was to compare intraoperative hemodynamic stability, volume loading and postoperative complications between group optimised with crystalloids and group optimised with colloids in patients undergoing neurosurgical procedure. The investigation will include 80 patients, 40 optimised with crystalloids and 40 with colloids.
Hemodynamic stability, volume loading, pooperative complications, hospital stay and mortality will be monitored during and aftre the surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one group will get crystalloids and one grou will get colloids for fluid optimisation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crystalloids
Arm Type
Active Comparator
Arm Description
Bolus of crystalloids
Bolus of 250 ml crystaloids will be infused regarding the measures
Arm Title
Colloids
Arm Type
Active Comparator
Arm Description
Bolus of colloids
Bolus of 250 ml colloids will be infused regarding the measures
Intervention Type
Drug
Intervention Name(s)
Sterofundin (Bolus of crystalloids)
Other Intervention Name(s)
Sterofundin
Intervention Description
Bolus of 250 ml crystaloids infused regarding the measures
Intervention Type
Drug
Intervention Name(s)
Voluven (Bolus of colloids)
Other Intervention Name(s)
Voluven
Intervention Description
Bolus of 250 ml colloids infused regarding the measures
Primary Outcome Measure Information:
Title
Consumption of optimisation fluid
Description
Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
The investigators will record the incidence of postoperative complications Complications in different organs will be recorded (nevrological, pulmological, cardiovascular, haematological, infection, wound). The investigator will evaluate the days in the hospital after the surgery and the mortality rate (the number of deaths) for the 15 days after the surgery or until death or the dissmision.
Time Frame
From the first day until 15 day after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
neurosurgery (tumour, vascular, adenoma), haemodynamic stability
Exclusion Criteria:
arrhythmia
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fluid Optimization With Crystalloids and Colloids in Neurosurgery
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