Best Solution Identification to Prevent Hyperchloremia Combinations of Sodium Chloride and Sodium Acetate IV Fluids Along With Standard of Care Treatment in Acute Stroke Patients

• Status: Recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis:

Hyper chloremia is associated with poor outcome in Intracerebral Hemorrhage (ICT). Hyperchloremia is defined as serum chloride level of 110mmol/L or greater. This clinical study is assuming that, by increasing the ratio of Sodium-acetate to Sodium-chloride solutions in IV treatment, the incidence of Hyperchloremia can be lowered significantly. This result can be demonstrated by measuring serum chloride levels at Baseline, 24Hr, 48Hr and 72 Hours' time intervals and compare them between the three treatment and one Control arm.

Intervention (drug/biologic/device/behavioral):

Phase 2-dose finding Patients will be enrolled in the study and randomized into one of the four study treatment arms(target fluid administration rate 1 ml/kg/hour) initiated within 12 hours. IVF will be prepared in the main hospital pharmacy.

1. Sodium chloride (0.9%) referred as 0.9% NaCl for 72 hours post symptom onset (60-72 hourspost randomization);

2. Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 3:1 ratio for 72 hours post symptom onset (60-72 hours post randomization);

3. Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 2:1 ratio for 72 hours post symptom onset (60-72 hours post randomization);

4. Sodium chloride (0.9%) and sodium acetate (0.9%) mixture 1:1 ratio for 72 hours post symptom onset (60-72 hours post randomization).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Collaborator: Zeenat Qureshi Stroke Institute

Criteria

Inclusion Criteria:

Age 18 years or older

Onset of new neurological deficits within 24 hours

NIHSS score of 4 or more

GCS score of 5 or more

CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cm3 OR CT scan consistent with Ischemic Stroke

Exclusion Criteria:

received Intravenous fluids for greater than 8 hours

Baseline Serum Chloride is greater than 110 mmol/L

Acute Kidney Injury

History of Chronic Renal Failure

Requirement of Hemodialysis or Peritoneal Dialyses Prior to Randomization