The aim of this study is to evaluate the effect of Glucose Insulin Potassium (GIK) solution infusion in acute heart failure (AHF) patients ; by measurement of serum NT-Pro BNP and Highly sensitive C-Reactive Protein (Hs-CRP) levels.
In a randomized, controlled, triple-blind clinical trial, 50 patients presented as AHF and referred to emergency department, who had left ventricular ejection fraction (LVEF) < 40% and no diabetes, hypoglycemia, hyperkalemia, and other conditions associated with high CRP level, were divided into two" control and intervention"groups .
Serum Nt-pro BNP and Hs-CRP levels were measured and standard therapy for AHF was started in either group at the time of hospital admission.
GIK solution including 300 mg/l glucose, 80 meq/l potassium and 50 u/l regular insulin at a rate of 1 cc/kg/h was administered to intervention group (25 persons) during 6 hours from admission and continued for 48 hours later. The placebo (normal saline serum) was administered to the control group (25 persons) by the same volume, rate and time.
Serum Nt-pro BNP and Hs-CRP levels were repeated in the 3rd and 5th days of admission in either group .The aforementioned data were recorded in forms and analyzed by statistic methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111238185N1
Registration date:2011-12-14, 1390/09/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-14, 1390/09/23
Registrant information
Name
Abolfazl Enaami
Name of organization / entity
Kermanshah university of medical sciences and health services
Country
Iran (Islamic Republic of)
Phone
+98 83 1836 0041
Email address
ab.enaami@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Kermanshah university of medical sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Glucose Insulin Potassium (GIK) infusion on serum Nt.Pro BNP and Hs-CRP levels in patients with acute heart failure
Public title
Effects of Glucose Insulin Potassium infusion on inflammatory markers in patients with acute heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias: All patients presenting as acute heart failure with left ventricular ejection fraction (LVEF) < 40%
Exclusion criterias: LVEF>40; Diabetes mellitus; Hypoglycemia; hyperkalemia; High Hs-CRP states including Infectious and Rheumatic diseases, cancers, Tissue damages, Burns and inflammatory bowel diseases.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah university of medical sciences
Street address
Kermanshah university of medical sciences, Shahid Beheshti blvd
City
Kermanshah
Postal code
Approval date
2011-11-12, 1390/08/21
Ethics committee reference number
40231
Health conditions studied
1
Description of health condition studied
Acute heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Hs-CRP
Timepoint
Before GIK administration, at 3rd and 5th days after GIK administration
Method of measurement
Blood test
2
Description
Nt Pro BNP
Timepoint
Before GIK administration, at 3rd and 5th days after GIK administration
Method of measurement
Blood test
Secondary outcomes
1
Description
Inhospital death
Timepoint
During hospital-stay period
Method of measurement
On the basis of vital sign
2
Description
Ventricular arrhythmias
Timepoint
During hospital-stay period
Method of measurement
On the basis of cardiac monitoring
Intervention groups
1
Description
Intervention group: 1 cc/kg/h GIK solution with formula 300 g/l glucose, 80 meq/l potassium, 50 u/l insulin during 48h.
Category
Treatment - Drugs
2
Description
Control group:placebo-serum isotonic solution with equal volume and speed
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Abolfazl Enaami-Resident of cardiology
Street address
Imam Ali hospital, Shahid Beheshti blvd ,Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Kermanshah university of medical sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Kermanshah university of medical sciences, Shahid Beheshti blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, Kermanshah university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Abolfazl Enaami
Position
Resident of cardiology
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti blvd ,Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1836 2022
Fax
Email
Ab.Enaami@kums.ac.ir; Enaami.Ab@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Hashem Kazerani
Position
Assistant professor of cardiology
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti blvd ,Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1837 0252
Fax
Email
HKAZERANI@HOTMAIL.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Abolfazl Enaami
Position
Resident of cardiology
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti blvd ,Kermanshah
City
Kermanshah
Postal code
Phone
Fax
Email
Ab.Enaami@kums.ac.ir; Enaami.Ab@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)