NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031200290

Registered date:12/01/2021

Safety evaluation of intranasal insulin administration

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedpatients with scheduled cardiac surgery requiring cardiopulmonary bypass
Date of first enrollment03/02/2021
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)preoperative intranasal insulin administration

Outcome(s)

Primary OutcomeHypoglycemia (blood glucose < 70/mg) after intranasal insulin administration
Secondary OutcomeChange in blood glucose at 30 and 40 min after intranasal insulin administration Change in plasma insulin at 10, 20, 30 and 40 min after intranasal insulin administration Change in plasma C peptide at 10, 20, 30 and 40 min after intranasal insulin administration Incidence of postoperative liver dysfunction Incidence of postoperative renal dysfunction Incidence of postoperative heart failure Incidence of postoperative infection Incidence of postoperative arrhythmia Incidence of death within 7days after surgery Incidence of postoperative delirium (POD) Change in intracerebral oxygen saturation (NIRS) during surgery Change in inflammatory cytokine (IL6, IL1 beta, TNF alpha)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1)Patients scheduled elective cardiac surgery or major vascular surgery with cardiopulmonary bypass 2)Patients who are 20 years old or older 3)Patients with 1.5 mg/dL or less preoperative creatinine 4)Patients who had not undergone nasal surgery 5)Patients with written consent 6)Patients who are able to communicate with Japanese
Exclude criteria1 Patients had 23 or less preoperative MMSE score 2 Patients with insulin allergy 3 Patients under mechanical ventilation 4 Patients with severe psychological disorder 5 Patients with severe liver dysfunction 6 Patients with severe infectious diseases 7)Patients with severe cerebral infarction 8)Patients with dyspituitarism or adrenal insufficiency

Related Information

Contact

Public contact
Name Akiko Kawakami
Address 1110 Shimokato, Chuo, Yamanashi, JAPAN Yamanashi Japan 409-3898
Telephone +81-55-273-1111
E-mail akawakami@yamanashi.ac.jp
Affiliation University of Yamanashi Hospital
Scientific contact
Name Akiko Kawakami
Address 1110 Shimokato, Chuo, Yamanashi, JAPAN Yamanashi Japan 409-3898
Telephone +81-55-273-1111
E-mail akawakami@yamanashi.ac.jp
Affiliation University of Yamanashi Hospital