Fluid Optimization With Crystalloids and Colloids in Neurosurgery

NCT ID: NCT03249298

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Crystalloids

Bolus of crystalloids

Bolus of 250 ml crystaloids will be infused regarding the measures

Group Type: ACTIVE_COMPARATOR

Sterofundin (Bolus of crystalloids)

Intervention Type: DRUG

Bolus of 250 ml crystaloids infused regarding the measures

Colloids

Bolus of colloids

Bolus of 250 ml colloids will be infused regarding the measures

Group Type: ACTIVE_COMPARATOR

Voluven (Bolus of colloids)

Intervention Type: DRUG

Bolus of 250 ml colloids infused regarding the measures

Interventions

Sterofundin (Bolus of crystalloids)

Bolus of 250 ml crystaloids infused regarding the measures

Intervention Type: DRUG

Voluven (Bolus of colloids)

Bolus of 250 ml colloids infused regarding the measures

Intervention Type: DRUG

Other Intervention Names

Sterofundin; Voluven

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• arrhythmia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Jasmina Markovic Bozic

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

OBKRGKOAIT216

Identifier Type: -

Identifier Source: org_study_id