Goal Directed Fluid Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Goal Directed Fluid Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ringerlactate lean

fluidtherapy with crystalloids in lean patients

Group Type ACTIVE_COMPARATOR

fluidotherapy with ringer-lactate

Intervention Type DRUG

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

Ringerlactate overweight

fluidtherapy with crystalloids in overweight patients

Group Type ACTIVE_COMPARATOR

fluidotherapy with ringer-lactate

Intervention Type DRUG

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

Ringerlactate obese

fluidtherapy with crystalloids in obese patients

Group Type ACTIVE_COMPARATOR

fluidotherapy with ringer-lactate

Intervention Type DRUG

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

Interventions

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fluidotherapy with ringer-lactate

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No