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.: PACTR201912769388623 Date of Approval: 10/12/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Pentoxifylline on Organ Dysfunction and Mortality in Severe Sepsis
Official scientific title Effect of Pentoxifylline on Organ Dysfunction and Mortality in Severe Sepsis
Brief summary describing the background and objectives of the trial Background: Sepsis and infection are among the leading causes of death world-wide. The annual burden of sepsis in high income countries is rising with mortality of 40% and 90% of the world wide deaths from pneumonia, meningitis or other infections occur in less developed countries. This study was done to evaluate the therapeutic efficacy of pentoxifylline as an adjuvant therapy in septic and its effect on multiple organ dysfunction and mortality in septic patients. Methods: This randomized double blinded prospective study was conducted from October 2017 to November 2018 included total sample size 52 cases of septic patients. Organ dysfunction was used as a primary outcome with proposed large effect size (0.8) and alfa =0.05 and power=0.80, so, 26 cases were needed in each group). Secondary outcomes were inflammatory markers (CRP and pro-calcitonin), duration of hospital stay, need for hemodialysis, need for vasopressor & inotropes, need for mechanical ventilation and 28 days survival. Results: Fifty two patients with sepsis were divided in 1: 1 ratio to receive pentoxifylline or not. The average age of the included patients was almost 53 years, chest disorders were the main cause of sepsis in both groups. There were no statistically significant differences between both groups in terms of SOFA score, lactate level, CRP level and pro-calcitonin level. As regards secondary outcomes, there were no statistically significant differences between study’s groups in terms of length of hospital stay (p =0.707), need for hemodialysis (p =0.541), need for vasopressor & inotropes (p =0.249), need for mechanical ventilation (p =0.703), and 28 days survival (p =0.5). Conclusion: We concluded that pentoxifylline as an adjuvant therapy in septic patients had no significant influence on multiple organ dysfunction and mortality.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) completed
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied sepsis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/09/2017
Actual trial start date 01/10/2017
Anticipated date of last follow up 07/09/2018
Actual Last follow-up date 08/11/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL https://scholar.google.com/citations?user=vcn8u0sAAAAJ&hl=en
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 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 pentoxiflylline pentoxifylline 1 mg/kg/hour intravenous maximum 1800 mg/day . during 28 days or until they were discharged from the intensive care unit or died receiving conventional sepsis therapy according to guidelines or to receive conventional sepsis therapy in addition to pentoxifylline 1 mg/kg/hour intravenous maximum 1800 mg/day during 28 days or until they were discharged from the intensive care unit or died. 26
Control Group placebo intravenous saline 28 days or until they were discharged from the intensive care unit or died. receiving conventional sepsis therapy alone according to guidelines or to receive conventional sepsis therapy in addition to saline1 mg/kg/hour intravenous during 28 days or until they were discharged from the intensive care unit or died. 26 Placebo
Control Group Pentoxifylline infusion maximum dose 1800 mg per day maximum Maximum 1800 mg per day 28 days Infusion therapy 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Adult patients with age ≥18 years. 2- Patients with severe sepsis. The diagnosis of sever sepsis was established according to the definitions of the Surviving Sepsis Campaign (SSC) (3). 3- Sepsis was due to either nosocomial pneumonia or pelvi-abdominal sepsis 1. Late septic shock at presentation with multiple organ failure. 2. APACHE II score on admission >25. 3. Preexisting liver cirrhosis. 4. Preexisting end stage renal disease 5. Pregnancy. 6. History of allergy or intolerance to Pentoxifylline. 7. Patient with malignancies 8. Uncontrolled hemorrhage 9. Burn 10. Previous steroid therapy 11. Death within 24 hours of ICU admission Adult: 19 Year-44 Year,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 23/11/2015 FACULTY OF MEDICINE AIN SHAMS UNIVERSITY Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
38 albassia cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome o Length of hospital stay. o Need for and duration of mechanical ventilation. o Need for and duration of vassopresor and inotropic support. o Need for haemodialysis every day till 28 days
Secondary Outcome Length of hospital stay , need for vasopressor or inotrops, need of mechanical ventilation, inflammatory markers CRP and procalcitonin, 28 days survival 28 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shams university hosptials 38 ELABASSIA- CAIRO 11561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
hanaa elgendy naser city cairo 11657 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor HANAA ELGENDY NASER CITY CAIRO 1657 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Hanaa A. Elgendy nasr city cairo 11765 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amr sobhy dr.amrsobhy2013@gmail.com 00201063394383 13 elmakwleen elarab
City Postal code Country Position/Affiliation
cairo 11771 Egypt lecturer at department of anesthesia ICU and pain management faculty of medicine ain shams university
Role Name Email Phone Street address
Public Enquiries amr sobhy dr.amrsobhy2013@gmail.com 00201063394383 13 elmakwleen elarab
City Postal code Country Position/Affiliation
cairo 11771 Egypt lecturer at department of anesthesia ICU and pain management faculty of medicine ain shams university
Role Name Email Phone Street address
Scientific Enquiries hanaa elgandy hanaa.elgendy@yahoo.com 00201001029544 nasr city
City Postal code Country Position/Affiliation
cairo 11765 Egypt associate professor at department of anesthesia ICU and pain management faculty of medicine ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patients with severe sepsis either nosocomial or pelviabdominal Study Protocol 4months Pentoxifylline infusion in sever sepsis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not published 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