Fluid Optimization With Crystalloids and Colloids in Neurosurgery

NCT03249298 | Completed

• 1 other identifier: OBKRGKOAIT216
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Consumption of optimisation fluid

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

  During surgery

Secondary Outcomes (1)

• Postoperative complications

  From the first day until 15 day after the surgery

Study Arms (2)

Crystalloids

ACTIVE COMPARATOR

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

Drug: Sterofundin (Bolus of crystalloids)

Colloids

ACTIVE COMPARATOR

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

Drug: Voluven (Bolus of colloids)

Interventions

Sterofundin (Bolus of crystalloids) DRUG

Bolus of 250 ml crystaloids infused regarding the measures

Also known as: Sterofundin

Crystalloids

Voluven (Bolus of colloids) DRUG

Bolus of 250 ml colloids infused regarding the measures

Also known as: Voluven

Colloids

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• arrhythmia

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

sterofundin; HES 130-0.4

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: one group will get crystalloids and one grou will get colloids for fluid optimisation

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: August 15, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)