Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/10/2007
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 M J Schultz

ORCID ID

Contact details

Department of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
m.j.schultz@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HiLoNali

Study hypothesis

We hypothesise that lung protective mechanical ventilation, using lower tidal volumes, attenuates mechanical ventilation induced pulmonary inflammation.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mechanical ventilation, complications

Intervention

Patients are randomly assigned to receive mechanical ventilation involving either traditional Tidal Volumes (VT) (10 ml/kg Predicted Body Weight [PBW]) or lower VT (6 ml/kg PBW). All patients will undergo a minilavage every second day, preceded by blood sampling.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Local inflammatory responses
2. Local Fibrin turnover
3. Systemic levels of biomarkers of lung injury

Secondary outcome measures

Late ALI/ARDS.

Overall trial start date

01/01/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who are intubated and expected to receive mechanical ventilation for greater than 72 hours are eligible for the study if they do not suffer from Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrom (ARDS), according to the American/European consensus criteria.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Greater than 36 hours after start of Mechnical Ventilation (MV)
2. Under 18
3. Participation in other trials
4. Pregnancy
5. Increased uncontrollable intracranial pressure
6. Severe chronic respiratory disease (daily medication)
7. Pneumonia
8. Use of corticosteroids (systemic or local) or other immunosuppressive agents
9. Pulmonary thrombo-embolism
10. After pneumonectomy or lobectomy
11. Previous randomisation in this study

Recruitment start date

01/01/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Intensive Care
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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

Publication citations

Additional files

Editorial Notes