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.: PACTR202301531884761 Date of Approval: 19/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title FLUID MANAGEMENT IN DIABETIC KETO- ACIDOSIS: NORMAL SALINE VS SALINE AND LACTATED RINGER
Official scientific title FLUID MANAGEMENT IN DIABETIC KETO- ACIDOSIS: NORMAL SALINE VS SALINE AND LACTATED RINGER
Brief summary describing the background and objectives of the trial Rehydration with crystaloid is the cornestone of management of Diabetic ketoacidosis in emergency department (ED),it aimes to restore fluid deficits, improve organ perfusion, maintien hemodynamic stability and prevent the developpement of acute kidney injury. Historically, 0.9% sodium chloride (saline) has been the most commonly administered intravenous fluid. Data suggest that intravenous saline may be associated with hyperchloremic metabolic acidosis, acute kidney injury, and death. Crystalloid solutions with electrolyte compositions closer to that of plasma (balanced crystalloids, such as lactated Ringer’s solution or Plasma-Lyte A) represents an increasingly used alternative to saline. Balanced solutions seem to improve delay of acido-basic correction and lengh of stay at the ED. Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults, but it is not known which results in better clinical outcomes. The main objective of the study is: To Compare the effectiveness of isotonic saline solution versus. Alternating isotonic saline solution and Ringer's lactate for the correction of fluid deficit in moderate to severe ketoacidosis. the secondary objectives are : The duration of hospitalization and the tolerance of the ISS + RL vs ISS solution alone
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 30/05/2023
Actual Last follow-up date 26/08/2023
Anticipated target sample size (number of participants) 230
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group NORMAL SALINE 24 HOURS The normal saline groupe will receive, for rehydration , 10% of the body weight of normal saline in the first 24h of the management of Diabetic ketoacidosis 115 Active-Treatment of Control Group
Experimental Group LACTATED RINGER 24 Hours the patient will receive 10% of the body weight, equally between lactated ringer and normal saline solution 115
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of both genders Aged more than 16 years old Admitted in the emergency department of moderate to severe ketoacidosis defined by: hyperglycemia > 2.5 g/L and Acetonuria > + and pH< 7.25; and HCO3- < 15 mmol/l Anion gap (AG) > 12 mmol/l - Patients with chronic renal failure (renal clearance less than 30 ml / minute - Patients with state of shock defined by: SBP < 90 mmHg with signs of peripheral hypoperfusion. - The association with severe pathology: Myocardial ischemia, Septic shock, Acute pancreatitis, Acute surgical pathology. -Patients transferred before the end of the protocol - Secondary hemodynamic instability requiring the use of vasoactive drugs - Withdrawal of consent. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 17/01/2022 Institutional committee of regional hospital of Ben Arous
Ethics Committee Address
Street address City Postal code Country
Medina jadida 3 Ben Arous 2065 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time (h) to recover from acidosis defined by a pH > 7.35 and HCO3- > 18 mmol/l The 24th hour
Secondary Outcome Total duration of stay in ED At the patients discharge
Secondary Outcome Incidence of hyperchloremic acidosis defined by pH< 7.35 with delta AG/delta bicarbonates < 1 After 24 hours of management
Secondary Outcome Incidence of cerebral edema After 24 hours of management and at discharge
Secondary Outcome developement of signs of overload After 24 hours of management
Secondary Outcome Impairment of kidney function After 24 hours of management
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Emergency department Regional hospital of Ben Arous Yasminette, madina jadida 3 Ben Arous 2065 Tunisia
Emergency department of hospital Habib Bougatfa Bizerte Pasteur Street Biezerte 7000 Tunisia
Emergency department of Mahmoud El Matri Hospital Ibn Khaldoun Street Ariana 2080 Tunisia
Emergency department of Tahar Maamouri Hospital Ezzeddine Chelbi Mrezgua Nabeul 8000 Tunisia
Emergency department Mongi Slim Hospital Sidi Daoud La Marsa Tunis 2046 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sami Souissi regional hospital of ben Arous Ben Arous 2065 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Souissi Sami regional hospital of Ben Arous Medina Jadida 3 Ben Arous 2065 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
Mabrouk Maroua Habib Bougatfa Hospital Bizerte 7000 Tunisia
khadija Zaouche Mahmoud el Matri hospital Ariana 2080 Tunisia
Chiraz ben Slimane Taher Maamouri Hospital Nabeul 8000 Tunisia
Walha Yassmine Mongi Slim Hospital Tunis 2046 Tunisia
Hela Ben Turkia regional hospital of Ben Arous BEN AROUS 2030 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sami Souissi samisouissi@yahoo.fr +21658443724 Regional hospital of BEN AROUS
City Postal code Country Position/Affiliation
BEN AROUS Tunisia Emergency departement
Role Name Email Phone Street address
Scientific Enquiries Hela Ben Turkia helabenturkia@gmail.com +21622544960 Regional hospital of Ben Arous
City Postal code Country Position/Affiliation
Ben Arous Tunisia emergency department
Role Name Email Phone Street address
Public Enquiries Sarra Akkeri akerisara@gmail.com +21658140939 Regional hospital of Ben Arous
City Postal code Country Position/Affiliation
Ben Arous 2065 Tunisia Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be available after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediatly after publication and no end date Anyone who wishes to access to the data at anytime. He should contact the principal investigator Pr Sami Souissi by mail (samisouissi@yahoo.fr)
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