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.: PACTR202207871325490 Date of Approval: 11/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DExtrose as a MAiNtenance fluiD in Septic shock (DEMANDS) trial
Official scientific title DEXTROSE 5% VERSUS NORMAL SALINE AS MAINTENANCE FLUID THERAPY IN PATIENTS WITH SEPTIC SHOCK; A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Fluid administration represents a mainstay of therapy in hemodynamically unstable patients and is probably the most common intervention in critical care overall. Accordingly, the upgraded recommendations of the surviving sepsis guideline favour an aggressive fluid resuscitation for as long as the patient continues to improve hemodynamically. On the other hand, it is well known that a positive fluid balance represents an independent predictor of mortality in critically ill patients. Inadvertent fluid and resultant sodium and chloride loading is often unintended and include fluids used as a diluent for drug infusions and boluses (fluid creep) and fluids used for maintenance and replacement purposes. These sources also account for more than half of the daily administered fluid volume in critically ill patients. There is a lot of debate whether isotonic or hypotonic maintenance solutions should be used. Data in children showed that hypotonic solutions carry the risk of hyponatremia and neurologic complications. However, studies in healthy adults indicate that administration of isotonic solutions (0.9% NaCl) will result in a more positive fluid balance as compared to hypotonic solutions (5% Dextrose). This was confirmed in a recent pilot study in healthy volunteers showing that isotonic solutions caused lower urine output, characterized by decreased aldosterone concentrations indicating (unintentional) volume expansion, than hypotonic solutions. Despite their lower sodium and potassium content, hypotonic fluids were not associated with hyponatremia or hypokalemia. The aim of this study is to establish the feasibility, safety, biochemical and physiological efficacy of 5% dextrose compared with 0.9% NaCl for fluid maintenance therapy and fluid creep in critically ill septic shock patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DEMANDS
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied septic shock
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2022
Actual trial start date
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet 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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dextrose as per treating physician 72 hours Maintenance and creep fluid 50
Control Group normal saline as per treating physician 72 hours manitenance and creep fluid 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Septic shock defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥ 65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.  Age ≥ 18 years.  Need for maintenance fluid as determined by the treating clinician  Study intervention can be administered within 1 h of inclusion criteria being met.  Clinical situations that would render the primary endpoint difficult to interpret: • Chronic diuretic or decompression use. • Liver failure. • Treatment with parenteral feeding. • Confirmed or suspected pregnancy. • Patients in whom death is considered imminent (within 24 hours)  Potential patient harm by the study fluids: • Severe heart failure. • Patients with intracranial pathology (eg; traumatic brain injury, Stroke). • Electrolyte disorders;  A sodium level below 130 mmol/L or over 150 mmol/L or  A potassium level below 3 mmol/L or over 5 mmol/L   Adult: 19 Year-44 Year 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 21/01/2021 Alexandria faculty of medicine ethics committee
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, El Mesalah, Alexandria, Egypt Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The net cumulative fluid balance after 72 hours in ICU. after 72 hours in ICU.
Secondary Outcome • All-cause mortality at 28 days post randomization. 28 days
Secondary Outcome • The relative change in haemodynamic variables, blood gas results Lactate, and electrolytes over the 72 h post randomization. 72 hours
Secondary Outcome ICU length of stay till patient discharge
Secondary Outcome duration of vasopressor requirement till patient discharge
Secondary Outcome vasopressor free days till patient discharge
Secondary Outcome dose of vasopressor used till patient discharge
Secondary Outcome requirement for ventilation till patient discharge
Secondary Outcome duratin of ventilator support till patient discharge
Secondary Outcome ventilator free days till patient discharge
Secondary Outcome requirement for renal replacement therapy till patient discharge
Secondary Outcome duration of renal replacement therapy till patient discharge
Secondary Outcome renal replacement therapy free days till patient discharge
Secondary Outcome AKIN score to day 7 day 7
Secondary Outcome serum sodium 72 hours
Secondary Outcome delirium incidence till patient discharge
Secondary Outcome delirium and coma free days till patient discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university 17 Champollion street , EL Messala, Alexandria , Egypt Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed 39 nabi danial Alexandria 21517 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine Alexandria university 17 champollion street, EL Messalah, Alexandria , Egypt Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Akram fayed 17 champollion street, EL Messalah, Alexandria , Egypt Alexandria 21521 Egypt
samaa abdelfattah 47 omar elmokhtar louran Alexandria 21529 Egypt
mohamed abdelaleem 160 roushdy Alexandria 21529 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Osman mohamedosman888888@gmail.com 00201091156143 39 Nabi danial street, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria 21517 Egypt assisstan lecturer
Role Name Email Phone Street address
Scientific Enquiries Akram fayed amfayed@gmail.com 00201001721546 17 champollion street, ELMessalah, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt professor
Role Name Email Phone Street address
Public Enquiries Samaa Abdelfatah Samaa.daoud@outlook.com 00201062409640 47 omar elmokhtar louran ,Alexandria,Egypt
City Postal code Country Position/Affiliation
Alexandria 13722 Egypt assisstant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes unidentified individual participant data sheet Study Protocol 2 years after publication access is granted after approval by trial committee
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