Goal Directed Fluid Therapy - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00860704

Purpose

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

Condition	Intervention	Phase
Fluid Management	Other: fluidotherapy with ringer-lactate Other: fluidotherapy with hydroxyethylstarch 6%	Phase IV

MedlinePlus related topics: Esophagus Disorders Obesity

Drug Information available for: Lactic acid Ammonium lactate Ringer's lactate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

different hemodynamic fluid responses in the different groups [ Time Frame: every 10 minutes during surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subcutaneous oxygen tension (PsqO2) [ Time Frame: every 10 minutes during surgery and 2 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
crystalloids lean: Active Comparator fluidotherapy with crystalloids in lean patients	Other: fluidotherapy with ringer-lactate a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler
colloids lean: Active Comparator fluidotherapy with colloids in lean patients	Other: fluidotherapy with hydroxyethylstarch 6% a bolus of 250ml hydroxyethylstarch 6% is administered, if there is fluid demand monitored by the Esophageal Doppler
crystalloids obese: Active Comparator fluidotherapy with crystalloids in obese patients	Other: fluidotherapy with ringer-lactate a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler
colloids obese: Active Comparator fluidotherapy with colloids in obese patients	Other: fluidotherapy with hydroxyethylstarch 6% a bolus of 250ml hydroxyethylstarch 6% is administered, if there is fluid demand monitored by the Esophageal Doppler

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 compare the impact of different fluid regimens on tissue oxygenation.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860704

Contacts

Contact: Andrea Holzer, MD	0140400 ext 4107	andrea.holzer@meduniwien.ac.at
Contact: Edith Fleischmann, MD	0140400 ext 4107	edith.fleischmann@meduniwien.ac.at

Locations

Austria
Medical University Vienna	Recruiting
Vienna, Austria, 1090
Contact: Andrea Holzer, MD 0140400 ext 4107 andrea.holzer@meduniwien.ac.at
Contact: Edith Fleischmann, MD 0140400 ext 4107 edith.fleischmann@meduniwien.ac.at

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Andrea Holzer, MD

Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine

More Information

Publications:

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.

Responsible Party:	Medical University of Vienna ( Andrea Holzer, MD )
Study ID Numbers:	EK 299/2006
Study First Received:	March 11, 2009
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00860704 History of Changes
Health Authority:	Austria: Federal Ministry for Health Family and Youth

Keywords provided by Medical University of Vienna:

goal directed fluid therapy
lean patients
obese patients
crystalloids

colloids
Esophageal Doppler
tissue oxygenation
Fluid management during surgery

Study placed in the following topic categories:

Obesity
Esophageal Disorder
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009