Fluid Optimization With Crystalloids and Colloids in Neurosurgery

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Drug: Voluven (Bolus of colloids); Drug: Sterofundin (Bolus of crystalloids)

• Registration Number: NCT03249298
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-15
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• neurosurgery (tumour, vascular, adenoma), haemodynamic stability

Exclusion Criteria

• arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colloids	Voluven (Bolus of colloids)	Bolus of colloids Bolus of 250 ml colloids will be infused regarding the measures
Crystalloids	Sterofundin (Bolus of crystalloids)	Bolus of crystalloids Bolus of 250 ml crystaloids will be infused regarding the measures

Primary Outcome Measures

Name	Time	Method
Consumption of optimisation fluid	During surgery	Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	From the first day until 15 day after the surgery	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.

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia