Goal Directed Fluid Therapy

Phase 4

Completed

• Conditions: Goal Directed Fluid Therapy
• Interventions: Drug: fluidotherapy with ringer-lactate

• Registration Number: NCT00860704
• Lead Sponsor: Medical University of Vienna

Brief Summary

Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.

Detailed Description

To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI \<25) vs. obese patients (BMI \>25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)

Exclusion Criteria

• cardiac insufficiency (EF< 35%)
• renal insufficiency (creatinin clearance <30ml/min, dialysis)
• insulin dependant diabetes mellitus
• coagulopathy
• NYHA IV
• infection
• sepsis
• history of suspect malignant hyperthermia
• porphyria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringerlactate lean	fluidotherapy with ringer-lactate	fluidtherapy with crystalloids in lean patients
Ringerlactate overweight	fluidotherapy with ringer-lactate	fluidtherapy with crystalloids in overweight patients
Ringerlactate obese	fluidotherapy with ringer-lactate	fluidtherapy with crystalloids in obese patients

Primary Outcome Measures

Name	Time	Method
different hemodynamic fluid responses in the different groups	every 10 minutes during surgery

Secondary Outcome Measures

Name	Time	Method
Subcutaneous oxygen tension (PsqO2)	every 10 minutes during surgery and 2 hours postoperatively

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria