Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000365561
Ethics application status
Approved
Date submitted
19/10/2014
Date registered
22/04/2015
Date last updated
22/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perioperative calcium, magnesium and phosphorus levels in living donors for liver transplant
Scientific title
Perioperative calcium, magnesium and phosphorus levels in living donors for liver transplant
Secondary ID [1] 285519 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PELDLT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative calcium, magnesium and phosphorus levels in living donors for liver transplant 293328 0
Condition category
Condition code
Surgery 293596 293596 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Days
Description of intervention(s) / exposure
We will perform a retrospective analysis of the perioperative data of 44 donors who underwent right lobe hepatectomy for living related liver transplantation in our centre to characterize the incidence of hypocalcemia, hypomagnesemia and hypophosphatemia among this patient population. We will collect the following data: operative time, urine output, total amount of crystalloid and colloid administered, and the values of serum ionized calcium, magnesium and phosphorus at preoperative day and postoperative days 0, 1 and 2. The normal ranges of serum calcium, magnesium and phosphorus will be defined as 2.2-2.5 mmol/L, 0.7-1 mmol/L and 0.8-1.6 mmol/L respectively. the overall duration of observation in participants is 4 days (preoperative day and 3 days in intensive care).
Intervention code [1] 290460 0
Not applicable
Comparator / control treatment
we will compare between levels of calcium, magnesium and phosphorus during pre-operative period, day 0 post-operative, day 1 post-operative and day 2 post-operative in living donors underwent hepatectomy for liver transplantation. we will assess if there is significant difference between values.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293407 0
Serum assay is used to detect if there is significant change in serum calcium level peri-operative in donors for living liver transplant
Timepoint [1] 293407 0
observational retrospective study; serum calcium is assessed on preoperative day and post-operative at day 0, 1 and 2.
Primary outcome [2] 294710 0
Serum assay is used to detect if there is significant change in serum magnesium level peri-operative in donors for living liver transplant
Timepoint [2] 294710 0
observational retrospective study; serum magnesium is assessed on preoperative day and postoperative at day 0,1 and 2.
Primary outcome [3] 294711 0
Serum assay is used to detect if there is significant change in serum phosphorus level peri-operative in donors for living liver transplant
Timepoint [3] 294711 0
observational retrospective study; serum phosphorus is assessed on preoperative day and on postoperative day 0,1 and 2.
Secondary outcome [1] 310953 0
to detect any morbidity associated with change in serum level of electrolytes by electrocardiogram assessment for any arrythmias and clinical assessment for change in motor power of the patients
Timepoint [1] 310953 0
electrocardiogram and clinical assessment on post-operative at day 0, 1 and 2.

Eligibility
Key inclusion criteria
- ASA physical status I.
- age 21-40 years.
- donors underwent hepatectomy for living liver transplantation.
Minimum age
21 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- ASA physical staus II or more.
- age more than 40 years old.
- patients who underwent massive intra-operative blood loss and required blood transfusion for rescucitation.
- patients who required re-exploration for post-operative bleeding.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
data are expressed as mean and chi-square-t test is used to compare between values (pre-operative, day 0, day 1 and day 2)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2014
Actual
15/09/2014
Date of last participant enrolment
Anticipated
1/10/2014
Actual
1/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 6425 0
Egypt
State/province [1] 6425 0
cairo

Funding & Sponsors
Funding source category [1] 290112 0
Self funded/Unfunded
Name [1] 290112 0
Ahmed Abdelaal Ahmed Mahmoud
Country [1] 290112 0
Egypt
Primary sponsor type
Individual
Name
Ahmed Abdelaal Ahmed Mahmoud
Address
work organisation: Beni Suef University hospital
corresponding address:Egypt, cairo, nasr city, 7th district, 39 mousa ebn nousir street.
P.O. 11471
Country
Egypt
Secondary sponsor category [1] 288821 0
Individual
Name [1] 288821 0
Mohamed Mohamed Abdelhaq
Address [1] 288821 0
work organisation: Beni Suef University hospital
corresponding address:Egypt, cairo, nasr city, 7th district, 39 mousa ebn nousir street.
P.O. 11471
Country [1] 288821 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291828 0
research and ethics committee-faculty of medicine-beni suef university
Ethics committee address [1] 291828 0
Ethics committee country [1] 291828 0
Egypt
Date submitted for ethics approval [1] 291828 0
01/09/2014
Approval date [1] 291828 0
14/09/2014
Ethics approval number [1] 291828 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52182 0
Dr Ahmed Abdelaal Ahmed Mahmoud
Address 52182 0
work organisation: Beni Suef University hospital
corresponding address:Egypt, cairo, nasr city, 7th district, 39 mousa ebn nousir street.
P.O. 11471
Country 52182 0
Egypt
Phone 52182 0
+20 1113308866
Fax 52182 0
Email 52182 0
[email protected]
Contact person for public queries
Name 52183 0
mohamed mohamed abdelhaq
Address 52183 0
work organisation: Cairo University hospital
corresponding address:EGYPT- Cairo- al manial- faculty of medicine- cairo university- department of anesthesia.
Country 52183 0
Egypt
Phone 52183 0
+20 1000053764
Fax 52183 0
Email 52183 0
[email protected]
Contact person for scientific queries
Name 52184 0
Ahmed Mostafa Alsharawy
Address 52184 0
Egypt- Beni Suef governorate-Beni Suef city, Beni Suef University- faculty of medicine- department of anesthesia- 3 mokbl street, P.O. 62511
Country 52184 0
Egypt
Phone 52184 0
+20 1141015584
Fax 52184 0
Email 52184 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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