Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism

Effects of Urinary Kallidinogenase on NIHSS Score, mRS Score, and Fasting Glucose Levels in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism: a Prospective Cohort Study

Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the impact of urinary kallidinogenase on NIHSS score, modified Rankin scale (mRS) score and fasting glucose levels in patients with AIS combined with diabetes mellitus and impaired fasting glucose.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Abnormal Glucose Metabolism
• Intervention / Treatment: Drug: Urinary Kallidinogenase

Detailed Description

Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort study and divided into two groups. The HUK group were treated with urinary kallidinogenase and standard treatment, the control group received standard treatment. NIHSS scores, mRS scores and fasting blood glucose were evaluated and compared.

• Study Type: Observational
• Enrollment (Actual): 113

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with AIS combined with diabetes mellitus and impaired fasting glucose who was meets the Inclusion and Exclusion Criteria were enrolled in this prospective cohort study and divided into two groups.

Description

Inclusion Criteria:

• Aged 18-75 years (male or female)
• Patients were admitted to hospital within 72h of stroke onset
• Diagnosis of acute ischemic stroke according to the criteria stated in the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China (2010), and patients were confirmed as acute ischemic cerebrovascular disease by head computed tomography (CT) or magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI)
• NIHSS score ranged from 3-21 points
• Patients were previously diagnosed with type 2 diabetes, in which they were in line with the 2006 WHO diagnostic criteria for diabetes, or they had fasting blood glucose of 6.1-6.9mmol/L and glycosylated hemoglobin (HbA1C) of>6.1%
• Patients could cooperate with the test and evaluation of relevant indicators in the trial.

Exclusion criteria:

• Pregnant or lactating women
• Patients with severe heart, liver and kidney dysfunction
• Patients with a history of cerebrovascular disease and who still suffered from serious neurological dysfunction that had an influence on the trial
• Patients with physical disabilities, joint deformities or muscle lesions
• Patients were confirmed with intracranial hemorrhage by CT
• Patients were allergic to the study drug
• Patients suffering from severe systemic infection
• Patients who had participated in other clinical trials within 1 month
• For any reason, the researchers believed that the subject was unlikely to complete the study (such as cerebral infarction caused by cerebral embolism, intracranial arteritis, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) and moyamoya disease; patients undergoing thrombolysis or thrombectomy after admission; patients and their families were unable to cooperate with follow-up.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HUK group; On the basis of routine treatment for cerebral infarction, patients in the HUK group were also given Urinary Kallidinogenase at 0.15 PNA unit/day, for a 10-day course.	Drug: Urinary Kallidinogenase; Other Names: Kai Li Kang
control group; The control group were given routine treatment for cerebral infarction, including anti-platelet aggregation, anticoagulation, lipid-lowering and plaque stabilizing, free radical scavenging, nerve nutrition and brain protection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS Score at 90 Days	Comparison of NIHSS score between the control and HUK group at 90 days	at 90 days after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS Score at 10 Days、30 Days	Comparison of NIHSS score between the control and HUK group at 10days、30days.	at 10 days, 30 days after admission
Factors related to Non-General Recovery (90-day NIHSS was reduced by <90%)	Based on NIHSS score，multivariate analysis was performed to evaluate the factors related to non-general recovery (90-day NIHSS was reduced by <90%) for all patients. Evaluation of NIHSS score: General recovery was when NIHSS score was reduced by 90%-100%; Non-general recovery referred to when NIHSS score was reduced by <90%.	at 90 days after admission
mRS Score	The mRS score of 10 days after admission was taken as the baseline.Comparison of mRS score between the control and HUK group at 30days、90days. Based on mRS，multivariate analysis was also performed to evaluate the factors related to poor curative effect (90-day mRS ≥3) for all patients. Evaluation of mRS score: mRS score of 0-2 points referred to a good curative effect, and 3-5 points referred to a poor curative effect.	10 days, 30 days, and 90 days after admission
fasting glucose levels	Comparison of the change in fasting glucose levels between the control and HUK group at admission and 10days.	at admission and 10 days after admission

Collaborators and Investigators

• Sponsor: The Second Hospital of Hebei Medical University
• Investigators: Principal Investigator: Xiaopeng Wang, MD, The Second Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ACTUAL): October 1, 2017

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Physiological Effects of Drugs; Coagulants; Reproductive Control Agents; Fertility Agents; Fertility Agents, Male; Kallikreins
• Other Study ID Numbers: 2016261