Evaluation of Patients With Critical Illness

This protocol is designed as a training study, to permit evaluation and treatment of
subjects with critical illnesses. A data base, not otherwise obtainable, will be collected
of disease processes related to critical illness. Observation of the short-term effects of
intensive care interventions will also take place. Minimal studies scheduled for each
admission will include a medical history and physical examination, monitoring of hemodynamic
status, routine laboratory tests, and evaluation for possible causes of the critical
illness. Treatment plans will be individualized for each patient's condition, and the number
and length of additional visits and diagnostic evaluations will vary accordingly. Any
medical care recommended or provided to the patient will be consistent with routine
standards of practice as outlined in Clinical Center (CC) and Critical Care Medicine
policies. In selected patients, blood samples may be stored for future research.

The CC is a JCAHO-accredited medical facility with protocols both for standard medical care
and also for research. The Critical Care team is made up of intensivists, critical care
fellows, nurses, nurse practitioners, and a pharmacist. All of the intensivists are
certified in one or more medical subspecialties including critical care and/or cardiology,
infectious diseases, pulmonology, and anesthesiology. The CC Medical Intensive Care Unit
(MICU) is a state-of-the-art facility that provides comprehensive care for patients with
multi-organ failure, sepsis, and medical emergencies. There are daily multi-disciplinary
rounds. Attending physicians are in-house during normal business hours and on-call at home
at night. A MICU Fellow is always available in-house.

Suitable candidates for this study could include critically ill patients with a diagnostic
or therapeutic dilemma, an unusual presentation of disease, or a disease requiring novel
therapy available at the CC. Because inter-hospital transfer of the critically ill may
increase patient risk, patients will be accepted only if there is a likely medical benefit
that outweighs the risk of transfer and if the risk of transfer is thought to be acceptable
by both the referring and accepting physicians.

Critically ill patients represent a vulnerable population because of serious illness that
may affect their ability to make decisions. They must have an identified durable power of
attorney designated for decision making, prior to transfer to the CC.

The risks of this study include the risk of transfer of a critically ill patient from one
facility to another and the risks of standard or accepted medical care. There may be no
benefit to participation in this study.

In addition to the care available through enrollment in this protocol, patients may also
enroll in other NIH protocols if they wish.

The establishment of this protocol will provide a means to evaluate and treat patients, and
to generate hypotheses and protocols based on this clinical experience in critical illness.

- INCLUSION CRITERIA

Patients are subject to selection by the principal and associate investigators, and will
fit any of the following criteria:

Patient with critical illness, who, in the opinion of the accepting physician, may obtain
medical benefit by transfer to the CC.

Patient requiring ICU admission according to the SCCM and CCMD guidelines for ICU or
intermediate care admissions and with a diagnosis or probable diagnosis on the ICU
training protocol diagnosis list or a diagnosis deemed to be appropriate for staff
training.

Patient not on the diagnosis list may be admitted at the discretion of the attending
physician, if there is prospect of direct medical benefit to the patient.

Age 18 years or older.

Patient may or may not be able to give consent. If the patient is competent, he/she will
give written consent prior to transfer to NIH. If the patient is unable to provide
informed consent, written witnessed consent will be obtained from the appointed Durable
Power of Attorney.

Patient may or may not have other chronic illness.

Patient may be receiving medications for chronic illness treated by their private primary
care physicians.

Patient who lacks primary medical care outside the NIH may be enrolled in this protocol,
if an appropriate referral can be made to a competent healthcare provider who has agreed
to assume care when the patient is discharged.

Patient currently on other NIH protocols requiring ICU admission may be included in this
study.

The benefit of transferring the patient to the NIH out weighs the risk of the transfer for
the patient.

Available ICU bed in the MICU.

EXCLUSION CRITERIA

Patients with the following problems will be excluded from study:

Patient who does not require critical care.

Patient for whom further therapy is deemed futile by the attending physician.

Patient with known pregnancy, prior to enrollment in the protocol.

Any concurrent condition (medical, social, behavioral), which in the opinion of the
medical team would preclude or confound acquisition/interpretation of data or delivery of
clinical care.

Less then 18 years of age.

Any patient not requiring ICU admission according to the SCCM and CCMD guidelines for ICU
or intermediate care admissions or without a diagnosis or probable diagnosis on the ICU
training protocol diagnosis list.

Risk of transfer out weighs the benefit of the transfer for the patient.

No Durable Power of Attorney.