Trial record 15 of 326 for:    Open Studies | "Cardiac Surgical Procedures"

Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Xijing Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01398722
First received: July 11, 2011
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.


Condition Intervention Phase
Cardiac Surgery
Other: Intensive insulin therapy
Other: Conventional insulin therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biochemical markers of myocardial injury(troponin and creatine kinase MB) [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
  • Acute renal failure [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
  • Respiratory failure [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
  • ICU and hospital length of stay, and ICU readmissions [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
  • Stroke and reversible ischemic neurologic deficit [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
  • Cardiac Index [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
  • Inotropic Scores [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
  • Perioperative complications [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
    Perioperative complications including sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias


Estimated Enrollment: 800
Study Start Date: August 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensive insulin therapy
Intensive insulin therapy(Blood glucose target: 110-150 mg/dL)
Other: Intensive insulin therapy
Titration of the IV insulin rate for glucose goal 110-150 mg/dL
Active Comparator: Conventional insulin therapy
Conventional insulin therapy(Blood glucose target: 150-180 mg/dl)
Other: Conventional insulin therapy
Titration of the IV insulin rate for glucose goal 150-180 mg/dl

Detailed Description:

Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • Therapy restricted upon admission
  • Preoperative liver or kidney disease or dysfunction
  • Preoperative coagulation disorder
  • Palliative operation or a second operation
  • Type 1 diabetes
  • Type 2 diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398722

Contacts
Contact: Chunhu Gu, MD guchunhu@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hospital Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Chunhu Gu, MD       guchunhu@fmmu.edu.cn   
Principal Investigator: Chunhu Gu, MD         
Principal Investigator: Yukun Cao, MD         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: Dinhhua Yi, MD Xijing Hospital
  More Information

No publications provided

Responsible Party: Chunhu Gu, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01398722     History of Changes
Other Study ID Numbers: Guch-012
Study First Received: July 11, 2011
Last Updated: July 19, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
cardiac surgery
prognosis
intensive insulin therapy

Additional relevant MeSH terms:
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014