Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a multicenter, prospective, randomized, controlled study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fakultni Nemocnice Brno

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Nervous System Diseases [C10]

Trial duration

27 Nov 2025 → ongoing

Decision date (initial)

2024-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AZV grant sources or Brno University Hospital grant sources

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

The primary objective of the clinical trial is to determine the effect of GDHT guided by the non-invasive Starling™ SV System on the incidence of postoperative complications in patients undergoing neurosurgical intervention.

Secondary objectives 4

1. To investigate additional safety information
2. Comparison of hemodynamic characteristics and their changes over time between study groups
3. Comparison of laboratory values of selected blood parameters and their changes over time between study groups
4. Comparison of fluid balance and fluid therapy between study groups

Conditions and MedDRA coding

elective neurosurgery treating unspecified brain conditions

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years
2. Elective brain surgery with an expected duration ≥ 2 h
3. Category 1-3 according to the ASA Physical Status Classification
4. Lateral or supine operative position
5. Signed the relevant informed consent form

Exclusion criteria 8

1. Category 4 according to the ASA Physical Status Classification
2. Surgery for traumatic brain injury or acute hemorrhagic stroke
3. Awake brain surgery
4. Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards)
5. Unavailability of hemodynamic monitoring data
6. Cardiac arrhythmia with irregular cardiac rhythm
7. Known hypersensitivity to the active substance or to any of the excipients of IMP
8. Pregnancy and lactation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups.

Secondary endpoints 4

1. Duration of surgery, LOS, ICU LOS, 28-day mortality, descriptive analysis of the incidence of any adverse events and reactions
2. MAP, HR, SVV, number of episodes of hypotension, number of vasopressor administrations
3. Hemoglobin, plasma lactate level
4. Volume of blood loss, urinary output, number of administered units of packed RBC, number of subjects receiving transfusion, crystalloid and colloid solutions consumption, boluses of crystalloids

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fakultni Nemocnice Brno

Sponsor organisation

Fakultni Nemocnice Brno

Address

Jihlavska 340/20, Bohunice Bohunice

City

Brno

Postcode

625 00

Country

Czechia

Scientific contact point

Organisation

Fakultni Nemocnice Brno

Contact name

Ondřej Hrdý

Public contact point

Organisation

Fakultni Nemocnice Brno

Contact name

Michaela Kubelová

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications