Goal Directed Fluid Therapy

Goal Directed Fluid Therapy Clinical Trial

— FLO1  

Official title:

Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860704
• Other study ID #: EK 299/2006
• Status: Completed
• Phase: Phase 4
• Start date: November 2007
• Est. completion date: December 2012

Study information

• Verified date: October 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Goal Directed Fluid Therapy

Intervention

Drug:
• fluidotherapy with ringer-lactate
a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	different hemodynamic fluid responses in the different groups		every 10 minutes during surgery
Secondary	Subcutaneous oxygen tension (PsqO2)		every 10 minutes during surgery and 2 hours postoperatively