NCT00860704

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

5.1 years

First QC Date

March 11, 2009

Last Update Submit

October 17, 2018

Conditions

Goal Directed Fluid Therapy

Keywords

goal directed fluid therapylean patientsobese patientscrystalloidsEsophageal Dopplertissue oxygenationFluid management during surgeryFluid management

Outcome Measures

Primary Outcomes (1)

  • different hemodynamic fluid responses in the different groups

    every 10 minutes during surgery

Secondary Outcomes (1)

  • Subcutaneous oxygen tension (PsqO2)

    every 10 minutes during surgery and 2 hours postoperatively

Study Arms (3)

Ringerlactate lean

ACTIVE COMPARATOR

fluidtherapy with crystalloids in lean patients

Drug: fluidotherapy with ringer-lactate

Ringerlactate overweight

ACTIVE COMPARATOR

fluidtherapy with crystalloids in overweight patients

Drug: fluidotherapy with ringer-lactate

Ringerlactate obese

ACTIVE COMPARATOR

fluidtherapy with crystalloids in obese patients

Drug: fluidotherapy with ringer-lactate

Interventions

fluidotherapy with ringer-lactateDRUG

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

Ringerlactate leanRingerlactate obeseRingerlactate overweight

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

Related 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. doi: 10.1097/00000542-200210000-00012.

    PMID: 12357146BACKGROUND

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Andrea Holzer, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

November 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

AU(1)