Keratinocyte Growth Factor in Acute Lung Injury

• Research type

  Research Study

• Full title

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

• IRAS ID

  30368

• Contact name

  Daniel Francis McAuley

• Eudract number

  2010-021186-70

• Research summary

  Acute Lung Injury (ALI) causes the lungs not to function appropriately due to collection of pulmonarflud (oedema). ALI is common in critically ill patients in Intensive Care Units and is associated with a up to 50% mortality and a high morbidity in those who survive. There is a large economic burden with direct costs to the NHS but also indirectly due to the impact on the carer and patient through their inability to return to full time employment. There is little evidence for effective drug (pharmacological) treatment for ALI. Experiments have identified that cells which line the lungs (epithelial cells) are damaged and not functioning in ALI patients. A human protein called Keratinocyte Growth Factor (KGF) can help epithelial cells repair when damaged. Palifermin is a drug form of human KGF. Palifermin is currently licensed to help treat mouth ulcers in patients who have had chemotherapy or radiotherapy for certain cancers. This study will investigate whether giving palifermin can improve the damage to the lungs in patients with ALI as compared to patients who receive placebo i.e. dummy medication. Also the understanding of how ALI occurs will be investigated by measuring differences in inflammation and lung cell damage in the blood, urine anflud from the lining of the lung in these patients. It is anticipated that this study will investigate how effective palifermin maybe in patients with ALI and help identify a potential new therapy for future studies.

• REC name

  HSC REC B

• REC reference

  10/NIR02/32

• Date of REC Opinion

  4 Aug 2010

• REC opinion

  Further Information Favourable Opinion