The Fluid Therapy Strategy of the Non-dehydrated Patients With Acute Ischemic Stroke.

NCT02668848 | Unknown Phase 2 DMC

• 1 other identifier: CMRPG6e0401
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators previously found that a blood urea nitrogen/creatinine (BUN/Cr) ratio \>15 is an independent predictor of early deterioration after acute ischemic stroke. Another study was conducted to determine whether urine specific gravity, another indicator of hydration status and one more easily obtained, is also an independent predictor of early deterioration or stroke-in-evolution (SIE) in such patients. The investigators also conducted a preliminary study, enrolling ischemic stroke patients with a BUN/Cr ratio \>15 and find daily Bun/Cr based hydration help to decrease post stroke infection rate and improve 3 months functional outcome. In this study, daily urine specific gravity will be used to adjust hydration therapy in ischemic stroke patients with initial Bun/Cr ratio \<15. The primary outcome is the post stroke infection rate in the first 7 days after admission, and secondary outcome is 3 months functional outcome using mRS.

Conditions

Stroke; Dehydration

Keywords

Stroke; Dehydration; Fluid therapy

Outcome Measures

Primary Outcomes (1)

• the rate of post-stroke infection

  The post-stroke infection is defined as a core body temperature\>38C in any time point.

  the first 7 days after admission

Secondary Outcomes (1)

• functional outcome

  3 months after ischemic stroke

Study Arms (1)

urine monitoring group

EXPERIMENTAL

Patients of urine monitoring group will be checked for urine specific gravity (USG) once between 6a.m. to 12 m.d. in the first 5 days after admission. Patients will be advised to have water according to the level of USG.

Dietary Supplement: water

Interventions

water DIETARY_SUPPLEMENT

If USG\>1.02, patients will be advised to drink water via oral or tubal feeding with a dose of 5cc/kg body weight , maximum 300cc, and repeat the same amount of water after dinner in the same day.

urine monitoring 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 48 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 (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 (2)

• 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 RESULT

• Lin WC, Shih HM, Lin LC. Preliminary Prospective Study to Assess the Effect of Early Blood Urea Nitrogen/Creatinine Ratio-Based Hydration Therapy on Poststroke Infection Rate and Length of Stay in Acute Ischemic Stroke. J Stroke Cerebrovasc Dis. 2015 Dec;24(12):2720-7. doi: 10.1016/j.jstrokecerebrovasdis.2015.08.002. Epub 2015 Aug 31.

  PMID: 26338107 RESULT

MeSH Terms

Conditions

Stroke; Dehydration

Interventions

Water

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Leng C Lin, M.D.

  Department of Emergency Medicine, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leng C Lin, M.D.

CONTACT

+886 53621000; a3456711@ms65.hinet.net

Jen T Yang, PHD

CONTACT

+886 975353203; jents716@ms32.hinet.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: June 23, 2017

Record last verified: 2016-07

Locations

TW (1)