Skip to content

Intraoperative Goal-Directed Fluid Therapy in Lean and Obese Patients - n.A

Intraoperative Goal-Directed Fluid Therapy in Lean and Obese Patients - n.A

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002333-21-AT
Enrollment
40
Registered
2006-06-23
Start date
2006-07-28
Completion date
Unknown
Last updated
2013-07-15

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

Conditions

Hemodynamics in obese patients differ from lean patients: Obese patients have a higher cardiac output, the absolute amount of their intravascular volume is increased, as is the intracellular volume. The impact of these pathophysiological changes on perioperative fluid therapy is not known. Fluid optimisation has been considered as major contributor to improved oxygen delivery in patients. Hypovolemia has been associated with significant increases in morbidity and mortality.

Interventions

Pharmaceutical Form: Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use

Sponsors

Allgemeines Krankenhaus Wien, Medizinische Un iversität Wien
Lead Sponsor
Allgemeines Krankenhaus Wien, Medizinische Universität Wien
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: After IRB approval and written informed consent patients, aged 18-80, and scheduled consecutively for elective abdominal hysterectomy or myomectomy will be included in the study. Patients will be assigned to four groups. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: We will exclude patients having cardiac (ejection fraction<35%) or renal insufficiency (creatinine clearance < 30ml/min, or on renal replacement therapy), coronary (NYHA IV) or peripheral artery disease, insulin dependent diabetes mellitus, coagulopathies, symptoms of infection or sepsis, or a history of susceptibility to malignant hyperthermia or porphyria. Participants in other studies will be excluded, when an interference of the studies cannot be ruled out.

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare lean patients (Body Mass Index [BMI] 30) in regard of their respective needs for intraoperative fluid therapy. ;Secondary Objective: To compare crystalloids (Lactated Ringer’s solution [LR]) vs. colloids (Hydroxyaethylstarch Haes 6% 130/0.4 [Voluven®]) as intraoperative fluid therapy directed by predetermined goals. ;Primary end point(s): Tissue Oxgen Tension after Surgery Amount of volume requirement

Countries

Austria

Outcome results

None listed

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