Exertional Rhabdomyolysis Clinical Trial
Official title:
Rhabdomyolysis in Basic Training
The purpose of this study is to:
1. develop a normative database for serum creatine kinase (CK) responses to basic military
training (BMT);
2. determine the incidence of exertional rhabdomyolysis (ER) among a large cohort of
recruits undergoing BMT;
3. assess the impact of climate on the incidence of ER during BMT;
4. determine the incidence of candidate genes that may be associated with an increased
risk of ER.
Based on our review of scientific information, we have identified several genetic varieties
or polymorphisms that may be associated with an increased risk of muscle injury and/or heat
illness. As part of our recruitment process we have provided you with this written study
information, and will present to you a brief oral and PowerPoint presentation of the study
design and schedule, and the time to address any questions not yet answered prior to issuing
consent forms for those agreeing to participate.
Participation in this study is entirely voluntary; either agreeing or refusing to
participate will have absolutely no effect on your status as a recruit or your standing in
basic training. You will not be paid for your participation in this study. While your drill
sergeant and company commander will be aware of all those who are participating in the
study, this will occur only for scheduling purposes so that you and fellow participants can
be excused for the 3 blood draws that will take place after basic physical training has
begun. When you consent to participate in this study, you may place limitations on the use
of your blood sample by selecting one of the options provided on the last page of the
consent form. If at any point you decide not to continue in the study, detailed instructions
for withdrawal are in the consent form.
Potential Risks: Participation in this study itself will not increase your risk of
developing rhabdomyolysis. If you or any other participant should develop either
rhabdomyolysis or very high CK levels, we will perform additional DNA analyses for certain
conditions associated with exercise intolerance. Several of these are inherited muscle
diseases that may not be diagnosed until adulthood and may only first become apparent after
an episode of exercise intolerance. Diagnosis of any of these conditions is grounds for
dismissal from the Army, but it is essential that you and your family be aware of these
hereditary conditions if present.
Risks Associated With Genetic Analysis: There are certain additional risks that are uniquely
associated with any study involving genetic testing. Using advanced genetic analysis,
information about your DNA structure (genetic information) can help determine your risk of
developing certain genetic diseases that run in families. This genetic information is unique
to you and may indicate changes in your future health status or life expectancy, as well as
possibly, that of your children and other relatives. Besides medical risks, genetic testing
carries certain social risks. It can affect insurability, employability, personal family
planning, family relationships, immigration status, instigate paternity lawsuits, and be
associated with social stigmatization. Finding out that either you do or do not carry a gene
associated with a serious illness can cause both significant stress and psychological harm.
Privacy and Confidentiality: All information provided, as part of this study will be
confidential and protected to the fullest extent provided by law. Information and other
records related to this study will be accessible to those persons directly involved in
conducting this study and members of the Eisenhower Army Medical Center Institutional Review
Committee (IRC), USUHS Research Department, and other governmental agencies, which provides
oversight for protection of human research volunteers. All questionnaires, forms, and charts
will be kept in a restricted-access, locked cabinet while not in use and blood samples will
be stored in a restricted access, locked freezer at USUHS for up to five years, depending on
how participants wish their blood to be used. After five years all remaining blood samples
will be destroyed along with the code logbook. To enhance privacy of the information, all
data will be entered into a database in which individual responses are not identified. After
verification of the database information, all paper copies containing identifiers will be
shredded.
You will not be informed of the general results of the study since this is a research study,
but may review the literature for published results. However, if the results reveal that you
have a mutation in any gene that indicates susceptibility to specific disorders (malignant
hyperthermia, CPT II deficiency, McArdle's, AMP deaminase deficiency and MCAD deficiency),
you will be informed; we will also inform your General Medical Officer (GMO). If you need a
genetic counselor, we will arrange for this as well through your GMO. The genetic results
that are not associated with dismissal from military service will not be released to anyone
including you.
Complete confidentiality cannot be promised, particularly for military personnel, because
information bearing on your health may be required to be reported to appropriate medical or
command authorities.
Data Management: Data storage and analysis will be conducted on a desktop computer. The
computer storing these data will be backed up daily and only the PI and the data manager
will have access to the hard drive or discs. One copy of the disc will be maintained in a
secure locked office. A copy of the data set will also be stored on one the of the USUHS
servers by using a secure site, which is backed up daily.
Data files will be converted to SPSS™ datasets for processing and merging with other
participant research data. For the written questionnaires and forms, the project will use a
computer data management and analysis system composed of digital scanning technology with
Teleform™. This technique minimizes data entry errors and cleans data files on an on-going
basis. In addition, built-in range detection strategies will identify outliers that may
represent errors. In brief, forms completed by participants will be scanned by an optical
scanner and interpreted by Teleform™ Reader, which then checks for missing, illogical, and
out-of-range values. The Reader also identifies data that have been (1) incorrectly
completed, or (2) mistakenly marked, and (3) characters that do not satisfy the Reader's
confidence level. Those that do not meet these parameters are held for manual review and
correction. Correction is done with the Teleform™ Verifier. Once verification is complete,
the data are exported to SPSS™ database software for statistical analysis. The database is
programmed to check for illicit values and to calculate parameters derived from raw data.
Storage of Participant Samples: Your blood samples will be stored in appropriate conditions.
All samples will be given a numerical code and stored without participant name or any other
identifiers. This code will be entered into a logbook maintained by Dr. William Campbell or
appropriate persons. All samples will be stored at the USUHS for 5 years unless otherwise
instructed by the participant.
Use of Sample by Investigators: The protocol has specified the genes to be examined.
However, over the course of the study, other candidate genes with identified polymorphisms
may appear in the literature. If there is a clear justification for examining them for an
association to rhabdomyolysis, we will carry out the analysis after contacting you and
obtaining your permission. All of our analyses will relate specifically to the stated
objectives and not unrelated research efforts. There will not be any secondary use of the
samples obtained from the subjects since samples will not be shared with other investigators
outside this study. The blood samples obtained from this research will not be used for any
commercial purpose.
Withdrawal from Research: You have the right to withdraw from the study and have the option
of withdrawing your blood sample(s) at any time. If you decide to stop your participation in
the study, you need to contact the medical monitor and/or one of the members of the research
team and inform any one of them of your decision. They will withdraw you from the study and
no further blood samples, questionnaires or muscle exams will be performed. If your
participation in this study is stopped before the end of the study, any information that has
already been collected will be kept by the research team and included in study results. This
information will be maintained for the duration of the study.
Participant Resource: Members of the study team will be available to answer questions from
you at any time during the study, and in particular, during the three brief exams and blood
draws while in the field. In addition, the medical monitor of the study, Dr. Michael
Campbell, will also serve as the study ombudsman and be available as a resource to you or
any study participant.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01722448 -
Nutritional Prevention of Exertional Muscle Dysfunction
|
N/A |