Esophageal Doppler guided fluid management Improves blood lactate clearance in multiple Trauma Patients: a randomised controlled trial

ISRCTN ISRCTN07606792
DOI https://doi.org/10.1186/ISRCTN07606792
Secondary identifying numbers N/A
Submission date
03/10/2006
Registration date
19/10/2006
Last edited
26/04/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ivan Chytra
Scientific

Anesthesiology and Intensive Care Department
University Hospital
Alej svobody 80
Plzen
30460
Czech Republic

Email chytra@fnplzen.cz

Study information

Study designInterventional open randomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymEDITP
Study objectivesEarly optimisation of intravascular volume using esophageal Doppler in comparison with standard haemodynamic management may in multiple trauma patients improve blood lactate clearance and reduce organ dysfunction development.
Ethics approval(s)The study was approved by the Local Research Ethics Committee of University Hospital in Plzen on 10/05/2002.
Health condition(s) or problem(s) studiedMultiple trauma patients
InterventionPatients were randomised into protocol or control group according to the assigned admission number generated by admission office of hospital.

Fluid management in control group patients was managed using routine cardiovascular and clinical monitoring. Fluid resuscitation of protocol group patients was guided for first 12 hours of ICU stay according to the protocol based on data obtained by esophageal Doppler. After 12 hours the esophageal probe was removed and following fluid management in both groups was guided in the same way as in control group.
Intervention typeOther
Primary outcome measure1. Blood lactate clearance after 12 and 24 hours after ICU admission
2. Organ dysfunction development during ICU stay
Secondary outcome measures1. Duration of ICU and hospital stay
2. The incidence of infectious complications during ICU stay
Overall study start date01/03/2003
Completion date25/10/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participantsTarget number of participants was 160
Key inclusion criteriaVentilated patients with multiple trauma and estimated blood loss more than 2000 ml admitted to interdisciplinary Intensive Care Unit (ICU) of teaching university hospital in 2003 to 2005.
Key exclusion criteria1. Patients aged less than 18 years
2. Patients with traumatic brain injury requiring treatment of intracranial hypertension
3. Those with relative contraindications to the use of the esophageal Doppler probe, such as orofacial and esophageal injury or other known oropharyngeal and esophageal disease
Date of first enrolment01/03/2003
Date of final enrolment25/10/2005

Locations

Countries of recruitment

  • Czech Republic

Study participating centre

Anesthesiology and Intensive Care Department
Plzen
30460
Czech Republic

Sponsor information

Charles University (Czech Republic)
University/education

Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Czech Republic

Email office@lfp.cuni.cz
ROR logo "ROR" https://ror.org/024d6js02

Funders

Funder type

Government

The study was supported by the Czech Ministry of Education (project MSM0021620819) and by the Czech Ministry of Health (research grant IGA ND/7712-3).

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/08/2007 Yes No