GOULASH

GOULASH Logo The GOULASH trial is a randomized controlled two-arm double-blind multicentre trial. It will provide the first evidence concerning the necessity of early energy supply for patients suffering from acute pancreatitis.

Acute pancreatitis (AP) is an inflammatory disease with no specific therapy, however interventional basic research showed that ATP delivery restore the physiological functions of the cells suggesting that restoration of energy level of the pancreas is beneficial.

Patients suffering from acute pancreatitis will be randomly appointed to groups A (30kcal/kg/day energy administration started within 24h of hospital admission) and B (no energy administration in the first 24h of hospital admission). Multi organ failure for more than 48h and mortality are defined as primary endpoints, whereas several secondary endpoints will be determined.

The study is open for other centres. Who wish to join, needs to send a letter of intent to Péter Hegyi (hegyi2009@gmail.com).

Authorship policy: Centres providing more than 25 patients can provide two authors to the authors’ list. Every additional 25 patients will give the opportunity to nominate an author.

Ethical approval number: ETT TUKEB ad. 55961-2/2016/EKU
Trial registration number: ISRCTN63827758

Pre-study article: submitted to BMJ Open

Contact person:

Péter Hegyi Katalin Márta
HPSG Chair GOULASH Principal Investigator
Tel: +36 70 375 1031 Tel: +36 20 211 5868
e-mail: hegyi2009@gmail.com e-mail: katalin.martak@gmail.com

 



GOULASH Protocol (pdf)


GOULASH Form A (pdf)


GOULASH Form B (pdf)


GOULASH Form C (pdf)


GOULASH Ethical approval (pdf)