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American Heart Association

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Final ID: LBP50

A Randomized, Double Blinded, Phase 2B Clinical Trial to Compare the Safety and Efficacy of Sodium Chloride and Sodium Acetate Combination Intravenous Fluids in Acute Stroke Patients

Abstract Body: Background: Intravenous (IV) sodium chloride (0.9%) is the most common IV fluid used in acute stroke patients despite a high chloride load. Several studies have demonstrated a relationship between hyperchloremia, and death or disability in acute stroke patients. The therapeutic potential of IV fluids with lower chloride load in acute stroke patients has not been evaluated.
Objective: To identify the best” dose (ratio) of sodium chloride (0.9%) and sodium acetate (0.9%) mixture for reduction of hyperchloremia as IV fluids in patients with acute stroke initiated within 12 hours of symptom onset and continued for 72 hours.
Methods: Patients were randomized into one of the four study treatments: sodium chloride (0.9%) (group 1); and sodium chloride (0.9%) and sodium acetate (0.9%) mixture in ratios of 3:1 ratio (group 2), 2:1 ratio (group 3), and 1:1 ratio (group 4). All fluids were given at rate 1mg/kg/hour for 72 hours post symptom onset (60-72 hours post randomization). Serial serum chloride and creatinine concentrations were measured, and safety events were ascertained and adjudicated by an independent safety committee. Outcomes were ascertained at Day 30 and Day 90 post randomization using modified Rankin scale.
Results: Eighty acute stroke (64 ischemic stroke and 16 intracerebral hemorrhage) patients (were enrolled (20 in each treatment arm). The mean study IV fluid intake was three liters (range 2.5-3.6 liters). Compared with group 1, The mean serum chloride concentrations were significantly lower in groups 2, 3 and 4 at day 1(P=0.013) and day 2(P=0.014) with lowest chloride concentrations observed in group 4 (with highest sodium acetate content). None of the patients developed elevation in serum creatinine concentration >1.5 mg/dl in the first 3 days post randomization. There was no difference in proportion of patients with serious adverse events, functional independence between the four treatment groups. None of the reported adverse events were directly related to treatment IV fluids.
Conclusions: Sodium chloride and sodium acetate combination IV fluids were effective in reducing serum chloride concentrations in a dose dependent manner compared with sodium chloride IV fluid without any increase in safety events in acute stroke patients. The therapeutic potential of combination fluids should be further evaluated in larger randomized clinical trials in acute stroke patients.
  • Wasay, Muhammad  ( AGA KHAN HOSPITAL , Karachi , Pakistan )
  • Suri, Fareed  ( ST CLOUD HOSPITAL , Saint Cloud , Minnesota , United States )
  • Saleem, Shafaq  ( AGA KHAN HOSPITAL , Karachi , Pakistan )
  • Qureshi, Adnan  ( University of Missouri , Columbia , Missouri , United States )
  • Author Disclosures:
    Muhammad Wasay: DO NOT have relevant financial relationships | Fareed Suri: DO NOT have relevant financial relationships | shafaq Saleem: No Answer | Adnan Qureshi: DO have relevant financial relationships ; Ownership Interest:Qureshi Medical LLC:Active (exists now) ; Ownership Interest:QuReVasc LLC:Active (exists now) ; Ownership Interest:DyQure LLC:Active (exists now)
Meeting Info:
Session Info:

Late-Breaking Science Posters

Wednesday, 02/05/2025 , 07:00PM - 07:30PM

Poster Abstract Session

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