Fluid Optimization With Crystalloids and Colloids in Neurosurgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Crystaloids and Colloids for Fluid Optimization in Patients Undergoing Neurosurgical Procedure

Conditions
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Postoperative Complications

Intervention / Treatment
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* Drug: Sterofundin (Bolus of crystalloids)
* Drug: Voluven (Bolus of colloids)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neurosurgery (tumour, vascular, adenoma), haemodynamic stability Exclusion Criteria: arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: one group will get crystalloids and one grou will get colloids for fluid optimisation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crystalloids<br>Bolus of crystalloids Bolus of 250 ml crystaloids will be infused regarding the measures | Drug: Sterofundin (Bolus of crystalloids)<br>* Bolus of 250 ml crystaloids infused regarding the measures<br>* Other names: Sterofundin;|
| Active Comparator: Colloids<br>Bolus of colloids Bolus of 250 ml colloids will be infused regarding the measures | Drug: Voluven (Bolus of colloids)<br>* Bolus of 250 ml colloids infused regarding the measures<br>* Other names: Voluven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of optimisation fluid | Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the first day until 15 day after the surgery |