COOL Study Adverse Event and Serious Adverse Event Reporting Definitions

The COOL study is enrolling a cohort of extremely sick patients who are at high risk of death and por outcomes related to their underlying severe complicated intra-abdominal sepsis at enrolment. It s critical for patient safety however, that any potential adverse reaction that might be related to a patients participation in the study be reported to the Studies Sponsors. We are therefore requesting that both Suspected Unexpected Serious Adverse Reactions (SUSAR’s) and any Serious Adverse Reaction (SAR) that the Principle Investigator feels may be study related be reported promptly. To assist in this these situations are defined below.

All patients that develop any of the following SUSAR’s MUST be reported within 24 hours to Dr. Kirkpatrick:

· Death

· Enteroatmospheric fistulae

· Overt abdominal compartment syndrome

· Re-laparotomy in formally closed abdomens

· Any serious event that the PI sees as unexpected but related to the study

Due to the critical nature of these patients, EXPECTED adverse and serious adverse events are defined below. As these events are expected in this patient population they do not need to be reported as an adverse event, unless the local PI feels it should be reported, especially if the PI feels these events might have been at all related to any aspect of the study protocol and not from the primary critical illness. These include:

a) Multiple organ dysfunction including

a. Renal failure

b. Cardiovascular failure

c. Respiratory failure

d. Gastrointestinal failure

e. Hematopoietic failure

b) Prolonged life support

c) Intra-abdominal abscesses

d) Entero-cutaneous fistulae

e) Pneumonia

f) Deep vein thrombosis

g) Pulmonary embolism

h) Wound infections

i) Wound dehiscence

j) Prolonged hospitalization

k) Loss of independent living capability after release from hospital

l) General debility