NCT02099383

Brief Summary

The investigators' preliminary findings suggest that providing patients with acute ischemic stroke hydration therapy on the basis of their presenting BUN/Cr ratio may help reduce the occurrence of stroke-in-evolution(SIE) and therefore improve prognosis. The trial will be carried out in two parts. Part 1 assesses the rate of stroke-in-evolution 72 hours after the onset of stroke as a measure of the activity of BUN/Cr ratio based hydration therapy. Part 2, The investigators use two outcome measures, including Barthel index, and modified Rankin scale for neurological evaluation to assess whether BUN/Cr ratio based hydration therapy results in sustained clinical benefit at three months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P25-P50 for phase_3 stroke

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_3 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 8, 2021

Status Verified

November 1, 2018

Enrollment Period

6.3 years

First QC Date

March 26, 2014

Last Update Submit

September 5, 2021

Conditions

StrokeDehydration

Keywords

StrokeDehydrationFluid Therapy

Outcome Measures

Primary Outcomes (1)

  • rate of stroke-in-evolution

    Stroke-in-evolution is defined as a deterioration from base line in the score on the NIHSS by 4 or more points.

    72 hours

Secondary Outcomes (1)

  • rate of favorable outcome

    three months

Study Arms (2)

normal saline, bolus

ACTIVE COMPARATOR

Patients of study group will receive intravenous normal saline 20cc per kilogram of body weight, one third of which will be given as a bolus followed by delivery of the remaining two third as a constant infusion over a period of 8 hours.

Other: normal saline

normal saline, control

NO INTERVENTION

Patients of control group will receive intravenous normal saline 60 cc per hour.

Interventions

normal salineOTHER

intravenous normal saline 20cc per kilogram of body weight over a period of 8 hours

normal saline, bolus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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 12 hours
  • admission BUN/Cr≧15

You may not qualify if:

  • no informed consent obtained
  • initial NIHSS \>15
  • 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 (alanine aminotransferase or aspartate aminotransferase \> x 3 upper normal limit)
  • admission blood Cr \>2 mg/dl
  • initial systolic blood pressure \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

Location

Related Publications (2)

  • Lin LC, Yang JT, Weng HH, Hsiao CT, Lai SL, Fann WC. Predictors of early clinical deterioration after acute ischemic stroke. Am J Emerg Med. 2011 Jul;29(6):577-81. doi: 10.1016/j.ajem.2009.12.019. Epub 2010 Apr 2.

    PMID: 20825831BACKGROUND

  • Lin LC, Lee TH, Huang YC, Tsai YH, Yang JT, Yang LY, Pan YB, Lee M, Chen KF, Hung YC, Cheng HH, Lee IN, Lee MH, Chiu T, Chang YJ, Goh ZNL, Seak CJ. Enhanced versus standard hydration in acute ischemic stroke: REVIVE-A randomized clinical trial. Int J Stroke. 2024 Oct;19(9):1010-1019. doi: 10.1177/17474930241259940. Epub 2024 Jul 31.

    PMID: 38785314DERIVED

MeSH Terms

Conditions

StrokeDehydration

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Leng C Lin, MD

    Department of Emergency Medicine, Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

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

March 26, 2014

First Posted

March 28, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

September 8, 2021

Record last verified: 2018-11

Locations

TW(1)