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Completed

NCT Number: NCT03249298

Fluid Optimization With Crystalloids and Colloids in Neurosurgery

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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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • arrhythmia

Treatment and study plan

Sterofundin (Bolus of crystalloids)

Drug

Bolus of 250 ml crystaloids infused regarding the measures

Other names: Sterofundin

Voluven (Bolus of colloids)

Drug

Bolus of 250 ml colloids infused regarding the measures

Other names: Voluven

Primary outcomes

  1. Consumption of optimisation fluid

    Time frame: During surgery

    Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid

Secondary outcomes

  1. Postoperative complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Acronym: KOKR

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 15, 2017
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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