Evaluation of Patients With Critical Illness
|First Received Date ICMJE||December 23, 2004|
|Last Updated Date||June 26, 2010|
|Start Date ICMJE||December 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00100217 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of Patients With Critical Illness|
|Official Title ICMJE||Evaluation of Patients With Critical Illness: Intensive Care Training Protocol|
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:
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Critical Illness|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00100217|
|Other Study ID Numbers ICMJE||050062, 05-CC-0062|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP