Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204664745348 Date of Approval: 14/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ionized Hypocalcemia as a Prognostic Factor of Early Mortality in Traumatic Brain Injury
Official scientific title Ionized Hypocalcemia as a Prognostic Factor of Early Mortality in Traumatic Brain Injury
Brief summary describing the background and objectives of the trial Traumatic Brain Injury (TBI) is one of the most common neurological disorders. It is the leading cause of mortality and disability among young individuals.The incidence of TBI is rising , mainly due to increasing motor-vehicle use. Also, the incidence of TBI caused by falls is increasing as the population ages. This has consequences for the type of brain damage seen, and contusions (falls in older patients) are becoming more frequent than diffuse injuries (high-velocity traffic accidents in younger patients) . Different serum markers such as magnesium and calcium have been studied in context with TBI and calcium in particular seems to play an important role. Classically, hypocalcemia in the setting of trauma was thought to be solely secondary to the infusion of citrate with blood products. However, recent data have demonstrated that the majority of trauma patients are calcium deficient prior to transfusion of blood products which is furtherly exacerbated by the citrate from the transfusion. On the cellular level, transmembrane inflow of calcium and outflow of potassium due to traumatic deformation of the cellular membrane have been demonstrated following TBI; these are accompanied by the release of excitatory neurotransmitters such as glutamate. This increase in intracellular calcium causes an inhibition of mitochondrial enzymatic processes as well as lipase activation and therefore plays an important role in apoptotic processes . Hypocalcemia may be a consequence of calcium chelation by pro-inflammatory molecules/proteins such as Interleukin 6 (IL-6). Hence, an increase of metabolic molecules due to disruption of the aerobic mitochondrial pathway leads to acidosis with lactate being one of the key markers . The aim of this study is to investigate the prognostic value of ionized hypocalcemia in patients with TBI. -Primary outcome:mortality rate in patients withTBI with ionized hypocalcemia. -Secondary outcome: neurological deficit or organ dysfunction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Intensive care unit,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 26/03/2022
Actual trial start date 02/04/2022
Anticipated date of last follow up 05/10/2022
Actual Last follow-up date 05/10/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
FMASU MD 87/2022
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ionized hypocalcemia in patients with traumatic brain injury 30 days After admission of the patient to ICU in Ain Shams University Hospitals ,precise history taking ,physical examination and neurological assessment (conscious level, any deficit) and proper investigations including ionized calcium will be done. The admitted patients with TBI will be handled according to the guidelines of Advanced Trauma Life Support (ATLS) and according to the protocol of the ICU. Regarding sampling for ionized calcium, blood sample will be withdrawn anerobically and without pressure or tourniquet. It will be separated immediately from RBCs to avoid uptake of calcium by these cells (RBCs). Clinical variables at hospital admittance should include demographic and clinical data including hemodynamic data (respiratory and cardiac frequency, as well as, arterial pressures) and neurological assessment. All patients admitted to ICU will be evaluated for disease severity and its impact on body organs using acute physiology and chronic health evaluation II score (APACHE II) .Serum ionized calcium will be recorded on admisson , every other day and on discharge or death and if it is abnormal , it will be corrected. 30
Control Group Normal ionized calcium level in patients with traumatic brain injury 30 days After admission of the patient to ICU in Ain Shams University Hospitals ,precise history taking ,physical examination and neurological assessment (conscious level, any deficit) and proper investigations including ionized calcium will be done. The admitted patients with TBI will be handled according to the guidelines of Advanced Trauma Life Support (ATLS) and according to the protocol of the ICU. Regarding sampling for ionized calcium, blood sample will be withdrawn anerobically and without pressure or tourniquet. It will be separated immediately from RBCs to avoid uptake of calcium by these cells (RBCs). Clinical variables at hospital admittance should include demographic and clinical data including hemodynamic data (respiratory and cardiac frequency, as well as, arterial pressures) and neurological assessment. All patients admitted to ICU will be evaluated for disease severity and its impact on body organs using acute physiology and chronic health evaluation II score (APACHE II) .Serum ionized calcium will be recorded on admisson , every other day and on discharge or death. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients aged more than or equal 18 years old. 2- Patients of both sexes. 3- Patients admitted to hospital with traumatic brain injury. 1. Refusal of nearest relative to sign the written concept for study participation. 2. TBI older than 24 hours. 3. Diseases or medications affecting calcium metabolism such as hyperparathyroidism, acute pancreatitis and treatment with hydrochlorothiazide. 4. Recent history of hyperphosphatemia (>1.32 mmol/L) or hypomagnesemia (0.61 mmol/l). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/03/2022 Research Ethical Committee at Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality rate in patients with traumatic brain injury with ionized hypocalcemia Since admission of the patient to ICU till 30 days of ICU stay, every other day , if he is still admitted and on discharge or death
Secondary Outcome Neurological deficit or any organ dysfunction Since admission of the patient to ICU and for 30 days and follow up him after discharge to assess any deficit or any organ failure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The principle investigator 29 El Batrawy St., from Abbas El Akkad ,Nasr City Cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Jihad Mamdouh Mahanna Ahmed 29 El Batrawy St., from Abbas El Akkad , Nasr City Cairo 11765 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Jihad Mamdouh Mahanna Ahmed gehadmahanna@gmail.com 01002996361 29 El Batrawy St., from Abbas El Akkad , Nasr City
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Assistant Lecturer in Department of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Gamal Eldin Mohammad Ahmad Elewa gelewa@hotmail.com 01005195531 5 El Mashroaa El Swisri b , Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Anesthesia and Intensive care unit department Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Principal Investigator Ahmed Abd El Ghani KhalifaRagab Draag8385@hotmail.com 01063825286 9 Hassan Mahmoud St., El Nozha
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer at Anesthesia and ICU Department Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial, after de-identification Study Protocol Following publication Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information