Fluid Optimization With Crystalloids and Colloids in Neurosurgery (KOKR)

University Medical Centre Ljubljana

Status: Completed

Conditions: Postoperative Complications

Treatments: Drug: Sterofundin (Bolus of crystalloids); Drug: Voluven (Bolus of colloids)

Study type: Interventional

Funder types: Other

Identifiers

NCT03249298

OBKRGKOAIT216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• arrhythmia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Crystalloids

Active Comparator group

Description:

Bolus of crystalloids Bolus of 250 ml crystaloids will be infused regarding the measures

Treatment:

Drug: Sterofundin (Bolus of crystalloids)

Colloids

Active Comparator group

Description:

Bolus of colloids Bolus of 250 ml colloids will be infused regarding the measures

Treatment:

Drug: Voluven (Bolus of colloids)