Keratinocyte growth factor in Acute lung injury to REduce pulmonary dysfunction – a randomised placebo controlled trial (KARE) - Keratinocyte Growth Factor in Acute Lung Injury

• Conditions: Acute Lung Injury

• Registration Number: EUCTR2010-021186-70-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-08
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ALI as defined by acute onset of:
a.hypoxic respiratory failure (PaO2/FiO2 = 40 kPa)
b.bilateral infiltrates on chest X-ray consistent with pulmonary oedema.
c.no clinical evidence of left atrial hypertension or if measured, a
pulmonary arterial occlusion pressure (PAOP) less than or equal to 18 mmHg.
d.requirement for invasive positive pressure mechanical ventilation via an
endotracheal tube or tracheostomy

All ALI criteria (a-d above) must occur within the same 24-hour period. The onset of ALI is when the last ALI criterion is met. Patients must be enrolled within 72 hours of ALI onset.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Age < 18 years
2.More than 72 hours from the onset of ALI
3.Pregnancy
4.Participation in a clinical trial of an investigational medicinal product
within 30 days
5.Consent declined
6.Current treatment with KGF
7.Known hypersensitivity to palifermin or Escherichia coli derived proteins
8.Previous adverse reaction to palifermin.
9.History of active malignancy excludig haematological malignancies.
10.Chronic liver disease with Child-Pugh score greater than 12.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to test the hypothesis that palifermin will be effective in the treatment of patients with acute lung injury (ALI).<br><br>The trial objective is to undertaken a randomised double blind placebo controlled (i.e. dummy medication) clinical trial to study whether palifermin improves important surrogate markers of clinical outcome and is safe in adult patients with ALI in intensive care.;Secondary Objective: The secondary objectives are to investigate if palifermin has effect on important surrogate markers of biologic outcomes in ALI. This will help in the future design of other clinical trials with either with palifermin or with other potential therapeutic agents.;Primary end point(s): The primary endpoint of this clinical study is to evaluate the efficacy of palifermin to improve oxygenation index (OI) at day 7.