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Evaluation of different types of fluid

Evaluation of FLuid REsuscitation with Sterofundin ® ISO (Ringerfundin), Plasma-Lyte® or NaCl 0.9%. (FluReS study) - Evaluation of FLuid REsuscitation with Sterofundin ® ISO (Ringerfundin), or NaCl 0.9%. (FluReS study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-001005-41-BE
Enrollment
Unknown
Registered
2014-04-28
Start date
2014-12-10
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypovolemia-->need for fluid therapy

Interventions

Trade Name: Sterofundin Product Name: Sterofundin Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion Trade Name: NaCl 0,9 % solution for injection. Product Name: Sodium

Sponsors

Ghent University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Informed consent patient or legal representative 2. Treating physician decided for fluid bolus of 1 L administered over a 30-60 min time period. 3. Arterial catheter and urinary catheter. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Renal replacement therapy 2. <18 y 3. pregnant women 4. lactating women

Design outcomes

Primary

MeasureTime frame
Main Objective: Primary: Evaluate impact of fluid bolus with 1 L of Sterofundin, Plasma-Lyte ® and NaCl0.9 on acid-base status according to Stewart (SIDa and SIG). ;Secondary Objective: Secondary: • Compare the impact of fluid bolus with 1 L of Sterofundin, Plasma-Lyte and NaCl 0.9% on electrolytes, acid-base status, and osmolality. • Evaluate impact of fluid bolus with 1 L of Sterofundin, Plasma-Lyte and NaCl 0.9% on blood pressure and urine output. ;Primary end point(s): Primary: Evaluate impact of fluid bolus with 1 L of Sterofundin, Plasma-Lyte ® and NaCl on acid-base status according to Stewart (SIDa and SIG). ;Timepoint(s) of evaluation of this end point: SID

Secondary

MeasureTime frame
Secondary end point(s): Haemodynamic stability;Timepoint(s) of evaluation of this end point: HR Bloodpressure PH

Countries

Belgium

Contacts

Public ContactDepartment of Anaesthethics

Ghent University Hospital

Freekje.Viaene@gmail.com+3293322142

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026