DExtrose as a MAiNtenance fluiD in Septic shock (DEMANDS) trial

Phase 2

• Conditions: Circulatory System; septic shock

• Registration Number: PACTR202207871325490
• Lead Sponsor: faculty of medicine Alexandria university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

?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.

Exclusion Criteria

?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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•The net cumulative fluid balance after 72 hours in ICU.

Secondary Outcome Measures

Name	Time	Method
•All-cause mortality at 28 days post randomization.;<br>•The relative change in haemodynamic variables, blood gas results Lactate, and electrolytes over the 72 h post randomization.<br>;ICU length of stay;duration of vasopressor requirement ;vasopressor free days;dose of vasopressor used;requirement for ventilation;duratin of ventilator support;ventilator free days;requirement for renal replacement therapy;duration of renal replacement therapy;renal replacement therapy free days;AKIN score to day 7;serum sodium;delirium incidence;delirium and coma free days