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Fluid Optimization With Crystalloids and Colloids in Neurosurgery

NCT03249298 — Not applicable, Completed, 80 participants, University Medical Centre Ljubljana

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

RegistryNCT03249298, acronym KOKR
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment80 (Actual)
SponsorUniversity Medical Centre Ljubljana (Other)
ConditionsPostoperative Complications
InterventionsSterofundin (Bolus of crystalloids), Voluven (Bolus of colloids) (Drug)
Datesstart 2017-01-01, primary completion 2017-12-01, completion 2018-12-01, first posted 2017-08-15, last updated 2021-09-16
Locations1 site in Slovenia

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
CrystalloidsActive comparatorDrug: Sterofundin (Bolus of crystalloids)Bolus of crystalloids Bolus of 250 ml crystaloids will be infused regarding the measures
ColloidsActive comparatorDrug: Voluven (Bolus of colloids)Bolus of colloids Bolus of 250 ml colloids will be infused regarding the measures
  • Sterofundin (Bolus of crystalloids) (Drug), also known as Sterofundin: Bolus of 250 ml crystaloids infused regarding the measures
  • Voluven (Bolus of colloids) (Drug), also known as Voluven: Bolus of 250 ml colloids infused regarding the measures

+Outcome measures

Primary outcomes

  • Consumption of optimisation fluid [During surgery]: Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid

Secondary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

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

Exclusion Criteria:

* arrhythmia

+Locations (1)

FacilityCityCountryStatus
University Medical Centre LjubljanaLjubljanaSlovenia

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