Protocol Number: 05-CC-0062

Title:

Evaluation of Patients with Critical Illness: Intensive Care Training Protocol

Number:

05-CC-0062

Summary:

This study provides training opportunities for critical care specialists in evaluating and treating critically ill patients. Patients enrolled in the study receive standard tests and treatments. The study objectives are to:

- Provide additional training for staff of the NIH Clinical Center intensive care unit, including physicians, nurses, fellows, and other trainees so that they develop and maintain essential skills,

- Gather information about the natural history and outcomes of critical illness, accompanying conditions, and complications,

- Develop hypotheses about the medical problems involved in the illnesses and their treatment, and

- Identify critically ill patients who may be eligible for specific NIH research protocols.

Critically ill patients 18 years of age and older who may benefit by transferring to the NIH Clinical Center for treatment may be eligible for this study. Patients will be transferred to the Clinical Center from another hospital only when the referring and accepting physicians in both institutions agree that the potential benefit of coming to the NIH outweighs the risk of transferring the patient.

Participants are evaluated and treated at the Clinical Center. Patients provide a medical history and have a physical examination. They may also have various medical tests and procedures needed to evaluate their condition. These procedures may include blood work, placement of an intravenous (IV) line, x-rays and other imaging tests such as computed tomography (CT) or magnetic resonance imaging (MRI) and other procedures.

Patients who are diagnosed with a specific condition may be offered treatment or may be referred to another study that is more appropriate for that particular problem.

Sponsoring Institute:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

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.

Special Instructions:

Currently Not Provided

Keywords:

Training

Critical Care

Heart Failure

Pulmonary Hypertension

Infectious Diseases

Recruitment Keyword(s):

Critical Care

Condition(s):

Critical Illness

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

Warren G. Magnuson Clinical Center

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Parrillo JE, Cunnion RE, Epstein SE, Parker MM, Suffredini AF, Brenner M, Schaer GL, Palmeri ST, Cannon RO 3rd, Alling D, et al. A prospective, randomized, controlled trial of prednisone for dilated cardiomyopathy. N Engl J Med. 1989 Oct 19;321(16):1061-8.

Parker MM, McCarthy KE, Ognibene FP, Parrillo JE. Right ventricular dysfunction and dilatation, similar to left ventricular changes, characterize the cardiac depression of septic shock in humans. Chest. 1990 Jan;97(1):126-31. PMID: 2295231

Parker MM, Ognibene FP, Parrillo JE. Peak systolic pressure/end-systolic volume ratio, a load-independent measure of ventricular function, is reversibly decreased in human septic shock. Crit Care Med. 1994 Dec;22(12):1955-9.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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