Fluid Optimization With Crystalloids and Colloids in Neur... | NCT03249298

Studies
Fluid Optimization With Crystalloids and Colloids in Neurosurgery

NCT03249298

Sponsor

University Medical Centre Ljubljana

Status

Completed

Last Update Posted

Sep 16, 2021Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Postoperative Complications

Interventions

Sterofundin (Bolus of crystalloids)
Voluven (Bolus of colloids)

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2018Actual

First Submitted Date

Apr 7, 2017

First Submission Date that Met QC Criteria

Aug 9, 2017

First Posted Date

Aug 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2021

Last Update Posted Date

Sep 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jasmina Markovic Bozic, MD, PhD, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sterofundin (Bolus of crystalloids)	Drug	Bolus of 250 ml crystaloids infused regarding the measures	Crystalloids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Consumption of optimisation fluid	Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid	During surgery

Secondary Outcomes

Measure	Description	Time Frame
Postoperative complications	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neurosurgery (tumour, vascular, adenoma), haemodynamic stability

Exclusion Criteria:

arrhythmia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana		Ljubljana		1000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C052337	sterofundin
C485123	HES 130-0.4

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided