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 | Unknown Phase 2

• 1 other identifier: 2022-7608-22106
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.Sodium chloride (0.9%) referred as 0.9% NaCl for 72 hours post symptom onset (60-72 hourspost randomization);
2. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• hyperchloremia into one occurrence or two or more occurrences within first 72 hours hyperchloremia"

  hyperchloremia into one occurrence or two or more occurrences within first 72 hours hyperchloremia"

  72 hours

Study Arms (4)

Normal saline arm

ACTIVE COMPARATOR

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

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

normal saline sodium acetate 3;1

ACTIVE COMPARATOR

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

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

normal saline sodium acetate 2;1

ACTIVE COMPARATOR

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

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

normal saline sodium acetate 1;1

ACTIVE COMPARATOR

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

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

Interventions

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 DRUG

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

Also known as: Sodim chloride alone, sodium chloride with sodium acetate ratio 3;1, sodium chloride with sodium acetate ratio 2;1, sodium chloride and sodium acetate ratio 1;1

Normal saline arm; normal saline sodium acetate 1;1; normal saline sodium acetate 2;1; normal saline sodium acetate 3;1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• Zeenat Qureshi Stroke Institute: collaborator

Study Sites (1)

Aga Khan University

Karachi, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• MUHAMMAD WASAY

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMAD WASAY, MD FRCP FAAN

CONTACT

+923332234688; mohammad.wasay@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A Randomized, Blinded, Placebo-Controlled phase 2B clinical Trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: A Randomized, Blinded, Placebo-Controlled phase 2B clinical Trial

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 22, 2023
• Study Start: February 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 31, 2024
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)