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OpenTrials
Completed

NCT Number: NCT00860704

Goal Directed Fluid Therapy

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

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Key information

Conditions

Goal Directed Fluid Therapy

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluidotherapy with ringer-lactate

Drug

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

Primary outcomes

  1. different hemodynamic fluid responses in the different groups

    Time frame: every 10 minutes during surgery

Secondary outcomes

  1. Subcutaneous oxygen tension (PsqO2)

    Time frame: every 10 minutes during surgery and 2 hours postoperatively

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients

Acronym: FLO1

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 12, 2009
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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