NCT03810118 (REFILL) is a NA clinical trial of fluid challenge in Neurosurgery, sponsored by Humanitas Clinical and Research Center.

Who is sponsoring NCT03810118?

NCT03810118 is sponsored by Humanitas Clinical and Research Center.

What drugs are being tested in NCT03810118?

Interventions in NCT03810118: fluid challenge.

What condition does NCT03810118 study?

NCT03810118 studies Neurosurgery, Cardiovascular System, Anesthesia, General.

Is NCT03810118 still recruiting?

NCT03810118 is currently completed. Last updated 27 May 2020.

Last reviewed 2020-05-27 · How we verify

NCT03810118: REFILL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fluid Challenge Infusion and Response

Completed NA Last updated 27 May 2020

What this trial tests

NA trial testing fluid challenge in Neurosurgery in 49 participants. Completed in 1 May 2020.

Timeline

8 April 2019

Primary endpoint
21 February 2020

1 May 2020

Quick facts

Lead sponsor	Humanitas Clinical and Research Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	49
Start date	8 April 2019
Primary completion	21 February 2020
Estimated completion	1 May 2020
Sites	1 location across Italy

Drugs / interventions tested

fluid challenge — full drug profile →

Conditions studied

Neurosurgery — all drugs for Neurosurgery →
Cardiovascular System — all drugs for Cardiovascular System →
Anesthesia, General — all drugs for Anesthesia, General →

Sponsor

Humanitas Clinical and Research Center

Who can join

18 and older, any sex, with Neurosurgery or Cardiovascular System. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is unclear if the rate of administration of the fluid challenge could affect the rate of fluid responsiveness. The role of this small-dose (the so called mini-FC) has been recently tested to assess if the infusion of a small amount of fluids (100 ml in 1 minute) could predict the final effect of the residual aliquot (i.e., 250 ml of FC test subdivided as follows: 100 ml in 1 minute and 150 ml in 9 minutes). Both the sudden increase in the stroke volume and the reduction of PPV and SVV after a bolus of 100 ml of crystalloids administered in 1 minute showed high sensitivity and specificity in predicting the final outcome of the FC. The primary aim of the present study is assess whether the does the rate of infusion of fluid challenge affect fluid responsiveness in neurosurgical supine patients. The secondary aim is to assess the reliability of the changes in SV, PPV and SVV after a mini-FC test in predicting the final fluid responsiveness.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacodynamic analysis of a fluid challenge with 4 ml kg<sup>-1</sup> over 10 or 20 min: a multicenter cross-over randomized clinical trial.
Messina A, Palandri C, De Rosa S, Danzi V, et al · · 2022 · cited 24× · PMID 34494204 · DOI 10.1007/s10877-021-00756-3

Verify or expand the search:

Other trials of fluid challenge

Trials testing the same drug.

NCT06627907 — Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room. · not yet recruiting
NCT06839404 — Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS · recruiting
NCT02894996 — Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? · NA · completed

Other recruiting trials for Neurosurgery

Currently open trials in the same condition.

NCT06894238 — Electroencephalogram Predicts Post-operative Delirium · recruiting
NCT07046364 — Remimazolam and Emergence Delirium in Pediatrics · Phase 4 · recruiting
NCT06815861 — Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest (MOSCA-B) · active not recruiting
NCT05824338 — Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery · EARLY_PHASE1 · recruiting
NCT05951114 — Post-neurosurgical Respiratory Muscle Dysfunction · recruiting

Other Humanitas Clinical and Research Center trials

Trials by the same sponsor.

NCT07161297 — Remimazolam for Colonoscopy in IBD Patients · Phase 4 · not yet recruiting
NCT04934943 — "Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools" · not yet recruiting
NCT06394947 — Fluid Challenge in Intensive Care The FENICE II Study · completed
NCT06627907 — Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room. · not yet recruiting
NCT06099171 — Therapy With Paravertebral Oxygen-ozone Injections and Topical Cannabidiol and β-Caryophyllene Patch in Neck Pain · Phase 3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03810118 (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 Humanitas Clinical and Research Center
Last refreshed: 27 May 2020

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/NCT03810118.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing