Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100217
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-12-23
Brief Title:
Evaluation of Patients With Critical Illness
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Patients With Critical Illness Intensive Care Training Protocol
Status:
COMPLETED
Status Verified Date:
2010-06-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 patients 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CC-0062 | None | None | None |