Esophageal Doppler guided fluid management Improves blood lactate clearance in multiple Trauma Patients: a randomised controlled trial
ISRCTN | ISRCTN07606792 |
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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
Scientific
Anesthesiology and Intensive Care Department
University Hospital
Alej svobody 80
Plzen
30460
Czech Republic
chytra@fnplzen.cz |
Study information
Study design | Interventional open randomised controlled trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | EDITP |
Study objectives | 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(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) studied | 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 |
Primary outcome measure | 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 study start date | 01/03/2003 |
Completion date | 25/10/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | Target number of participants was 160 |
Key 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. |
Key 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 |
Date of first enrolment | 01/03/2003 |
Date of final enrolment | 25/10/2005 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Anesthesiology and Intensive Care Department
Plzen
30460
Czech Republic
30460
Czech Republic
Sponsor information
Charles University (Czech Republic)
University/education
University/education
Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Czech Republic
office@lfp.cuni.cz | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 01/08/2007 | Yes | No |