Clinical Trials Directory

Trials / Completed

CompletedNCT03249298

Fluid Optimization With Crystalloids and Colloids in Neurosurgery

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
University Medical Centre Ljubljana · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGSterofundin (Bolus of crystalloids)Bolus of 250 ml crystaloids infused regarding the measures
DRUGVoluven (Bolus of colloids)Bolus of 250 ml colloids infused regarding the measures

Timeline

Start date
2017-01-01
Primary completion
2017-12-01
Completion
2018-12-01
First posted
2017-08-15
Last updated
2021-09-16

Locations

1 site across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT03249298. Inclusion in this directory is not an endorsement.