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NCT03249298: KOKR
Comparison of Crystaloids and Colloids for Fluid Optimization in Patients Undergoing Neurosurgical Procedure
NA trial testing Sterofundin (Bolus of crystalloids) in Postoperative Complications in 80 participants. Completed in 1 December 2018.
1 December 2017
Quick facts
| Lead sponsor | University Medical Centre Ljubljana |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 January 2017 |
| Primary completion | 1 December 2017 |
| Estimated completion | 1 December 2018 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- Sterofundin (Bolus of crystalloids) — full drug profile →
- Voluven (Bolus of colloids) — full drug profile →
Conditions studied
- Postoperative Complications — all drugs for Postoperative Complications →
Sponsor
University Medical Centre Ljubljana
Who can join
Adults 18 to 80, any sex, with Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Consumption of optimisation fluid
Time frame: During surgery
Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Crystalloids vs. colloids for fluid optimization in patients undergoing brain tumour surgery.
Markovic-Bozic J, Visocnik B, Music P, Potocnik I, et al · · 2022 · cited 3× · PMID 36098062 · DOI 10.2478/raon-2022-0035 -
Crystalloids vs. colloids for fluid optimization in patients undergoing brain surgery
Markovic-Bozic J, Music P, Visocnik B, Spindler-Vesel A. · · 2021 · DOI 10.21203/rs.3.rs-948268/v1
Verify or expand the search:
- PubMed search for NCT03249298
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sterofundin (Bolus of crystalloids)
Trials testing the same drug.
- NCT07239713 — Clinical Effects of Ringers Lactate Versus Sterofundin/ Plasmalyte Solution in Patients With Sepsis · NA · recruiting
Other recruiting trials for Postoperative Complications
Currently open trials in the same condition.
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Other University Medical Centre Ljubljana trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03249298 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Centre Ljubljana
- Last refreshed: 14 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03249298.
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