KARE - Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunctio

Phase 2

Completed

• Conditions: Acute lung injury; Respiratory; Lung injury

• Registration Number: ISRCTN95690673
• Lead Sponsor: Belfast Health and Social Care Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-23
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Current inclusion criteria as of 23/01/2014:
1. Aged greater than 18 years, either sex
2. Acute lung injury (ALI) as defined by acute onset of:
2.1. Hypoxic respiratory failure (partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2] less than or equal to 40 kPa)
2.2. Bilateral infiltrates on chest X-ray consistent with pulmonary oedema
2.3. No clinical evidence of left atrial hypertension or if measured, a pulmonary arterial occlusion pressure (PAOP) less than or equal to 18 mmHg
2.4. Requirement for positive pressure mechanical ventilation via an endotracheal tube or tracheostomy
All ALI criteria 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.

Previous inclusion criteria:
1. Aged greater than 18 years, either sex
2. Acute lung injury (ALI) as defined by acute onset of:
2.1. Hypoxic respiratory failure (partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2] less than or equal to 40 kPa)
2.2. Bilateral infiltrates on chest X-ray consistent with pulmonary oedema
2.3. No clinical evidence of left atrial hypertension or if measured, a pulmonary arterial occlusion pressure (PAOP) less than or equal to 18 mmHg
2.4. Requirement for positive pressure mechanical ventilation via an endotracheal tube or tracheostomy
All ALI criteria 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 48 hours of ALI onset.

Exclusion Criteria

Current exclusion criteria as of 23/01/2014:
1. Aged less than 18 years
2. More than 48 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. Active history of malignancy excluding haematological malignancies
10. Chronic liver disease with Child-Pugh score greater than 12

Previous exclusion criteria:
1. Aged less than 18 years
2. More than 48 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. Patients with pancreatitis
8. Known hypersensitivity to palifermin or Escherichia coli derived proteins
9. Previous adverse reaction to palifermin
10. History of active malignancy
11. Chronic liver disease with Child-Pugh score greater than 12

Study & Design

• Study Type: Interventional
• Study Design: Not specified