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.: PACTR202307764415273 Date of Approval: 18/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Targeted Fluid Resuscitation in Septic Shock: A Comparative Study between Capillary Refilling Time and Venous to Arterial PCO2
Official scientific title Targeted Fluid Resuscitation in Septic Shock: A Comparative Study between Capillary Refilling Time and Venous to Arterial PCO2
Brief summary describing the background and objectives of the trial Adequate cell perfusion as a result of resuscitation in septic shock patients has been considered a critical point in the prognosis of these patients. There have been many parameters that can be followed up to achieve this target as increase the difference between arterial PCO2 and venous PCO2 more than 6 mmHg that has been considered as a signal of tissue hypo perfusion in septic shock patients. Therefore, pursuing to normalize this difference less than 6 mmhg may lead to the risk of fluid overload. Peripheral perfusion, assessed by the capillary refill time (CRT), could be an effective alternative resuscitation target as recently demonstrated by the ANDROMEDA-SHOCK trial. We designed the present randomized controlled trial to address the impact of a CRT-targeted (CRT-T) fluid resuscitation versus the difference of arterial PCO2 to venous PCO2 on fluid balances within 24 h of septic shock diagnosis
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied management of septic shock patients in ICU
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 21/09/2022
Actual trial start date 21/09/2022
Anticipated date of last follow up 01/07/2023
Actual Last follow-up date 23/06/2023
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group capillary refill time as prognostic 24 hours - The intervention of the study will be administration of repeated IV fluid boluses in the first 6 hours . Fluids (20 ml/kg of Ringer’s lactate administered within the first 3 hours ) and following the perfusion target (CRT less than 3 seconds ) is achieved in the first 6 hours , or fluid responsiveness is negative. 20
Control Group Venous to Arterial PCO2 difference measurement 24 hours - The intervention of the study will be administration of repeated IV fluid boluses in the first 6 hours . Fluids (20 ml/kg of Ringer’s lactate administered within the first 3 hours ) and following the perfusion target (the difference between the central venous carbon dioxide tension and the arterial carbon dioxide tension is less than 6 mmHg) is achieved in the first 6 hours , or fluid responsiveness is negative 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adult patients (aged 21-60 years) with septic shock. • Serum lactate>2 mmol/liter. • Requirements of norepinephrine (NE) to maintain a mean arterial pressure (MAP)≥65 mmHg after an intravenous fluid load of 20 ml/kg over 60 min. • Patients had to be recruited within a period of 24 h after septic shock diagnosis. • Pregnancy. • Peripheral vascular disease. • Anticipated surgery or dialysis. • Procedure during the first 6 h after potential inclusion. • Active bleeding. • Child B or C liver cirrhosis. • Severe acute respiratory distress syndrome (ARDS). Adult: 19 Year-44 Year 21 Year(s) 60 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 14/09/2022 Ain shams university faculty of medicine research ethics committee
Ethics Committee Address
Street address City Postal code Country
faculty of medicine , abbassya , el wayli Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum lactate measurement within ,first 6 hours intervention period baseline and every 2 hours during the 6 hours intervention period
Secondary Outcome 1- 24 h SOFA score. 2. fluid volume administrated during the 6 hours intervention period at baseline and every 2 hours during the 6 hours intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals 56th Ramses street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed I smail el narges 5 sth settlement Cairo 11815 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Ismail el narges 5th settlement Cairo 11815 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Ismail ahmedchelse1341991@gmail.com 01029914405 el narges 5
City Postal code Country Position/Affiliation
Cairo 11815 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Mostafa ryad drmkamel2002@gmail.com 01270742475 5th settlement
City Postal code Country Position/Affiliation
Cairo 11815 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Hoda Shokri Drhoda10@yahoo.com 01211179234 new cairo
City Postal code Country Position/Affiliation
Cairo 11815 Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data that will be shared is the individual participant data that underlie the results reported in this article after de identification ( text - tables and figures ) Informed Consent Form beginning 12 months after article publication to 24 months after publication Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of all applicable agreements (i.e. material transfer agreements)
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