BUN/Cr-based Hydration Therapy to Improve Outcome of Patients With Acute Ischemic Stroke

NCT05121389 | Unknown Phase 3 DMC

• 1 other identifier: CORPG6K0201
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

English Synopsis I. Title of Study: A trial of BUN/Cr-based hydration therapy to reduce stroke-in-evolution and improve short-term functional outcomes for dehydrated patients with acute ischemic stroke-version 2. II. Indication: We use blood urea nitrogen (BUN)/blood creatinine (Cr) ratio≧15 as a dehydration biomarker. This clinical trial aims to determine if more aggressive intravenous fluid supplement instead of present treatment would yield a better outcome in patients with acute ischemic stroke and a BUN/Cr ratio≧15. III. Phase of Development: Phase III, randomized double-blind control trial. IV. Study Rationale: We have recently reported a novel finding that the blood urea nitrogen (BUN)/creatinine (Cr) ratio, a marker of hydration status, was an independent predictor of early neurological deterioration among patients who had suffered acute ischemic stroke. Pilot study was then designed to determine if providing hydration therapy, specifically intravenous saline infusion, to patients with a blood urea nitrogen/creatinine ratio (BUN/Cr) ≥15 improves outcomes after acute ischemic stroke. The results showed that patients with a presenting BUN/Cr ≥ 15 who received saline hydration therapy experienced a better functional outcome compared with similar patients who received standard therapy. V. Study Objectives: Primary objective: To compare the effectiveness of BUN/Cr-based hydration therapy with standard treatment in early neurological improvement (ENI) rate at 72 hours for dehydrated subjects with acute ischemic stroke Secondary objectives: To compare the benefit of BUN/Cr-based hydration therapy with standard treatment after three months using measure of modified Rankin scale (mRS) VI. Study Design: Duration of Treatment: 12 hours Number of Planned Patients: 288 subjects Investigational Product: normal saline Endpoints:

1. 1.Primary endpoint: To compare the ENI rate between group at 72 hours. ENI is defined as the improvement of the NIHSS score by 2 or more points or a score of 1 or 0 at 72 hours after the onset of stroke.
2. 2.Secondary endpoints: To compare the rate of favorable functional outcome at 3 months. Scores \<=1 on the mRS are considered to indicate a favorable outcome.
3. 3.Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist.
4. 4.has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS)
5. 5.the time between the onset of neurological symptoms and starting therapy are less than 24 hours
6. 6.admission BUN/Cr≧15
7. 7.no informed consent obtained
8. 8.initial NIHSS \>10
9. 9.prepared for or received fibrinolytic therapy
10. 10.prepared for or received surgical intervention with 14 days
11. 11.congestive heart failure according to past history or Framingham criteria
12. 12.history of liver cirrhosis or severe liver dysfunction (ALT or AST \> x 3 upper normal limit)
13. 13.admission blood Cr \>2 mg/dl
14. 14.initial blood pressure SBP\<90 mmHg
15. 15.fever with core temperature \>=38°C
16. 16.indication of diuretics for fluid overload
17. 17.any conditions needed more aggressive hydration or blood transfusion
18. 18.cancer under treatment
19. 19.life expectancy or any reasons for follow-up \< 3 months

Conditions

Dehydration; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The rate of early neurological improvement at 72 hours after the onset of stroke

  early neurological improvement is defined as the improvement of the NIHSS score by 2 or more points or a score of 1 or 0

  72 hours after the onset of stroke

Secondary Outcomes (2)

• The favorable functional outcome at 3 months after the onset of stroke

  3 months after the onset of stroke

• the rate of early neurological deterioration at 72 hours of onset of stroke

  72 hours after the onset of stroke

Other Outcomes (1)

• The rate of early neurological improvement and deterioration in subgroup analysis according to TOAST classification

  72 hours after the onset of stroke

Study Arms (2)

study group

EXPERIMENTAL

Patients of study group will receive intravenous normal saline 30cc per kilogram of body weight, one fifth of which will be given as a bolus followed by delivery of the remaining four fifth as a constant infusion over a period of 12 hours.

Drug: normal saline

control group

SHAM COMPARATOR

Patients of control group will receive intravenous normal saline 10cc per kilogram of body weight as a constant infusion in the first 12 hours.

Drug: normal saline

Interventions

normal saline DRUG

Normal saline is injected intravenously, using a infusion rate control device to control the drip rate.

control group; study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist.
• has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS)
• the time between the onset of neurological symptoms and starting therapy are less than 24 hours
• admission BUN/Cr≧15

You may not qualify if:

• no informed consent obtained
• initial NIHSS \>10
• prepared for or received fibrinolytic therapy
• prepared for or received surgical intervention with 14 days
• congestive heart failure according to past history or Framingham criteria
• history of liver cirrhosis or severe liver dysfunction (ALT or AST \> x 3 upper normal limit)
• admission blood Cr \>2 mg/dl
• initial blood pressure SBP\<90 mmHg
• fever with core temperature \>=38°C
• indication of diuretics for fluid overload
• any conditions needed more aggressive hydration or blood transfusion
• cancer under treatment
• life expectancy or any reasons for follow-up \< 3 months

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

RECRUITING

Related Publications (1)

• Lin LC, Lee JD, Hung YC, Chang CH, Yang JT. Bun/creatinine ratio-based hydration for preventing stroke-in-evolution after acute ischemic stroke. Am J Emerg Med. 2014 Jul;32(7):709-12. doi: 10.1016/j.ajem.2014.03.045. Epub 2014 Apr 4.

  PMID: 24768671 BACKGROUND

MeSH Terms

Conditions

Dehydration; Ischemic Stroke

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• JT Yang, PHD

  Chang Gung Memorial Hospital, Chiayi Branch

  STUDY CHAIR

Central Study Contacts

LENG CHIEH LIN, Dr.

CONTACT

+88653621000; a3456711@ms65.hinet.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 16, 2021
• Study Start: January 7, 2021
• Primary Completion: November 30, 2022
• Study Completion: February 28, 2023
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)