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.: PACTR202312493987501 Date of Approval: 13/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title C-Reactive Protein/Albumin ratio versus Lactate/Albumin ratio as an outcome predictor for patients with sepsis and septic shock in hospital stay.
Official scientific title C-Reactive Protein/Albumin ratio versus Lactate/Albumin ratio as an outcome predictor for patients with sepsis and septic shock in hospital stay.
Brief summary describing the background and objectives of the trial Sepsis is a syndrome clinically characterized by physiological, biological, and biochemical abnormalities caused by an unregulated inflammatory response to infection. Multiple organ dysfunction and high mortality rates are outcomes of sepsis and inflammatory response. Sepsis is a clinical feature caused by severe inflammation that develops microcirculatory disorders in the patient, including activation of platelets and damage to endothelial cells. Lactic acidosis occurs as a consequence of tissue hypoxia in sepsis and septic shock . Elevated lactate levels are associated with poor clinical outcomes and high patient mortality.these levels are used for early diagnosis, management, and risk stratification in patients with sepsis/septic shock . albumin is a negative acute-phase protein, and its levels can reflect the magnitude of inflammation. C-Reactive Protein is a protein found in blood plasma, whose circulating concentrations rise in response to inflammation. This study aims to predict the prognostic values of CRP/Albumin ratio and Lactate/Albumin ratio in the outcome of patients with sepsis and septic shock in hospital stay , also to compare between them regarding sensitivity and specificity.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied severe sepsis and septic shock in Intensive Care Unit
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 17/11/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 26/11/2023
Actual Last follow-up date 26/12/2023
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group no intervention during hospital stay Observational Diagnostic Study 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adult confirmed septic patients (under the third international consensus definitions of sepsis and septic shock), admitted to ICU will be recruited. • Age (21-80) years. • Age: < 21 years old. • Patient refusal. • Pregnancy. • Malignancy. • Pathology that could affect serum albumin concentrations prior to ICU admission (e.g. nephrotic syndrome & cirrhosis & malnutrition). • Intestinal resection surgeries. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 80 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 18/11/2023 FMASU REC
Ethics Committee Address
Street address City Postal code Country
Abbasia , Cairo , Egypt Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to detect the mortality due to sepsis and septic shock in hospital stay, also measure C-Reactive Protein/Albumin ratio and Lactate/Albumin ratio . 1st day upon admission to ICU
Secondary Outcome The secondary outcomes are to know the duration of intensive care unit stay , the requirment for vasoactive medications (dose and duration in days) , mechanical ventilatory support (needed or not) and mechanical ventilatory days and need of renal replacement therapy . during stay in Intensive Care Unit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Intensive Care Units at Ain Shams University Hospitals Abbasia, Cairo , Egypt Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Madonna Mounir Salama Abbasia Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Madonna Mounir Salama Abbasia Cairo 11591 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Samia Abd El Mohsen Abdellatif Abbasia Cairo 11591 Egypt
Sameh Salem Hefny Abbasia Cairo 11591 Egypt
Mohamed Mohamed Kamal Abbasia Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Madonna Mounir donnamounir93@gmail.com 01228405957 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Lecturer of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Samia Abd El Mohsen samia.wahba1@hotmail.com 01001407487 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Professor of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Sameh Salem drsamehtaha@med.asu.edu.eg 01001587903 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Professor of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohamed MohamedKamal@med.asu.edu.eg 01003787898 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Lecturer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Madonna Mounir donnamounir93@gmai.com 01228405957 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Lecturer of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article,after deidentification(text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the date has been approved by an independent review committee can gain access for individual participant meta-analysis.
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