Condition category
Injury, Occupational Diseases, Poisoning
Date applied
03/10/2006
Date assigned
19/10/2006
Last edited
26/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ivan Chytra

ORCID ID

Contact details

Anesthesiology and Intensive Care Department
University Hospital
Alej svobody 80
Plzen
30460
Czech Republic
chytra@fnplzen.cz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

EDITP

Study hypothesis

Early 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

The study was approved by the Local Research Ethics Committee of University Hospital in Plzen on 10/05/2002.

Study design

Interventional open randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Multiple trauma patients

Intervention

Patients 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Blood lactate clearance after 12 and 24 hours after ICU admission
2. Organ dysfunction development during ICU stay

Secondary outcome measures

1. Duration of ICU and hospital stay
2. The incidence of infectious complications during ICU stay

Overall trial start date

01/03/2003

Overall trial end date

25/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Ventilated 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Target number of participants was 160

Participant exclusion criteria

1. 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

Recruitment start date

01/03/2003

Recruitment end date

25/10/2005

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Anesthesiology and Intensive Care Department
Plzen
30460
Czech Republic

Sponsor information

Organisation

Charles University (Czech Republic)

Sponsor details

Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Czech Republic
office@lfp.cuni.cz

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17313691

Publication citations

  1. Results

    Chytra I, Pradl R, Bosman R, Pelnár P, Kasal E, Zidková A, Esophageal Doppler-guided fluid management decreases blood lactate levels in multiple-trauma patients: a randomized controlled trial., Crit Care, 2007, 11, 1, R24, doi: 10.1186/cc5703.

Additional files

Editorial Notes