1.Reference ID:- 2018-02621
STUDY OF TOTAL CREATINE KINASE (CK)
LEVEL IN PATIENTS WITH SEIZURES AND THE EFFECT OF ANTI-EPILEPTIC DRUGS ON TOTAL
CREATINE KINASE (CK) LEVEL.
Epilepsy is the 4th most
common neurological problem. In India more
than 1 million cases of epilepsy are recorded every year. Even though Creatine
Kinase (CK) is evidently the most accessible parameter that can effectively
help us learn more about seizures there has not been significant amount of
research enabling us to understand the same.
seizure represents the clinical expression of abnormal, excessive, synchronous
discharges of neurons residing primarily in cerebral cortex. Epilepsy
considered to be a disease of the brain defined by any of the following
(1) At least, two unprovoked (or reflex)
seizures occurring >24 h apart; (2) one unprovoked (or
reflex) seizure and a probability of further seizures similar to the general
recurrence risk (at least 60%) after two unprovoked seizures, occurring over
the next 10 years; (3)
diagnosis of an epilepsy syndrome.
Creatine Kinase has been a standard
investigating parameter in the field of seizures (Epilepsy). The current
research focuses primarily in understanding the relationship between Total CK
and seizures and in turn assessing the intricate details of the same. The
agenda for the current research study has been to effectively assess the role of
Total CK in seizures and in turn evaluate the pharmacological effects of
various anti-epileptic drugs used in order to manage the medical condition of
seizures. As CK is also a direct indicator of extent of rhabdomyolysis the
study aims to predict and prevent acute renal failure and in turn act as a
precautionary entity for the same. The research aims to intervene with the very
fundamental aspects of drug prescription and its interaction in the patient
with a system of epileptic disorders.
On extraction of the required data
(Total CK values of a seizure patient over a course of time), I shall
systematically plot it over a graph comparing its quantity and time of
exhibition. The values collected involve the patient who is already diagnosed
with at least one or two episodes of seizure. The values collected involve the
assessment of patient’s prognosis over the anti-epileptic drug used in order to
manage the condition.
Thus, the current research focuses primarily in
understanding the relationship between Total CK and seizures and in turn
assessing the intricate details of the same. The agenda for the current
research study has been to effectively assess the role of Total CK in seizures.
1. To study the relationship between
seizures and Total Creatine Kinase.
2. To study the effect of Phenytoin
vs Levetiracetam on Total CK Level.
3. To identify and present the
sequential changes in the values of Total CK during the course of treatment of a Seizure.
Study design: Prospective Observational Study
Study period: 2 months
with seizures who are admitted within 24 hours of the seizure event.
who have been treated with Levetiracetam or Phenytoin.
above the age of 18 years.
seizure ( PNES )
who have received an IM injection
o Patients suffering from primary muscle
disorders like muscular dystrophies.
o Athletes They tend to have higher Creatine
Kinase (CK) levels
who have been treated with other Anti-Epileptic drugs apart from Levetiracetam
who have been admitted due to POLY TRAUMA.
Sample Size with Proper Justification:
Ø Sample size: 98
? According to a study performed by
Javali et al (2017), out of 100 patients subjected to study 36% of the patients presented with
generalized tonic–clonic seizures (GTCS). The next common presentation was
simple partial seizures (29%), complex partial seizures (CPS) (19%), and status
epilepticus (SE) (7%) at admission. 9% of patients were retrospectively
diagnosed to have PNES using video-EEG. Nearly 91.66% of patients with GTCS who
presented within 1 h had elevated CK whereas 70% of patients with partial
seizures had elevated Total CK.
In the present study expecting similar proportion;
considering absolute precision of 8%; to achieve a desired confidence level of
95%; the sample size worked out to 98 epileptic patients.
Detailed Description of Procedure:-
Selection of Subjects :-
98 Consecutive patients belonging to
the inclusion criteria and admitted to Ramaiah Memorial Hospital
Biochemical estimate Required :-
Creatine Kinase (CK) level.
Process of acquiring Total CK ( Creatine Kinase ) level :-
Reports of Serum Creatine Kinase
(CK) done as a part of the standard patient management protocol in epilepsy
(seizure) will be accessed and values will be recorded.
Serum Creatine Kinase (CK) is done
on Roche Cobas 6000 analyser by enzymatic colorimetric method in the diagnostic
laboratories in Ramaiah Memorial hospital.
Number of samples to be collected:-
Ø The Anti-Epileptic drug used for the
treatment of the condition is noted down for every subject.
Ø For every subject included in the
study a minimum of 3-4 consecutive serum total CK values will be recorded till
the post ictal phase is attained and the total CK level comes back to normal
Place of Study: – Ramaiah
Total Creatine Kinase Level
Potential Risks and Benefits: –
a. The blood sample collected as a part
of the routine investigations for Seizure (Epilepsy) would be used in this
study. Hence there is no introduction of any additional risks.
b. By conducting this study, we intend
to provide scope for a further study on Creatine Kinase as it is clinically
very important in the field of Diagnosis and Prognosis of Epilepsy.
Descriptive Statistics of values of
Total Creatine Kinase (CK) will be analyzed and summarized in terms of
o The values of Total Creatine Kinase (CK) in comparison with
the time of exhibition will be analyzed and summarized in pictorial
representations using valid Graphs.
o Chi-Square test would be used to compare Total Creatine Kinase (CK) normalization between different age
groups and sex.
A written informed consent form would be provided to the
participants. The participants will be informed about the procedure before
collection of the Total Creatine Kinase (CK) values.
o The research focusses on yielding a
result that enables us to understand the relationship between Total Creatine
Kinase (CK) level and Seizures.
o The research enables us to Predict
and Prevent Drug Induced Seizures and in turn act as a precautionary entity.
o The research aims to intervene with
the very fundamental aspects of drug prescription and its interaction in the
patient with a system of epileptic disorders.
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