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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

NCT05869565 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-05-22

No results posted yet for this study

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).

Conditions

  • Stroke, Acute

Interventions

DRUG

Sodium Chloride 0.9% infusion alone or in combination with Sodim acetate with normal saline in a ratio 1;1, 2;1 and 3;1

Patients will be enrolled in the study and randomized into one of four arms

Sponsors & Collaborators

  • Zeenat Qureshi Stroke Institute

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Principal Investigators

  • MUHAMMAD WASAY · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-02-28
Completion
2024-03-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05869565 on ClinicalTrials.gov