Blood flow change in the forearm after treatment of severely ill non-diabetic patients with insulin infusion

ISRCTN	ISRCTN39026810
DOI	https://doi.org/10.1186/ISRCTN39026810
Protocol serial number	N/A
Sponsor	General Hospital Celje (Slovenia)
Funder	General Hospital Celje (Slovenia) - Department for Education and Research

Submission date: 02/07/2009
Registration date: 29/07/2009
Last edited: 04/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ivan Zuran
Scientific

General Hospital Celje
Department of Angiology, Endocrinology, and Rheumatology
Celje
3000
Slovenia

Phone	+386 (0)3 423 3479
Email	ivan.zuran@yahoo.com

Study information

Primary study design	Interventional
Study design	Single centre interventional parallel group randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Intensive insulin treatment in critically ill patients and forearm blood flow: a randomised parallel group trial
Study objectives	Intensive treatment of critically ill patients with insulin to the range of serum glucose concentrations between 4.4 mmol/l and 6.1 mmol/l decreased the mortality rate in the group of patients treated at the department of intensive care following an operative procedure, while in medical patients such treatment had a favourable effect on the occurrence and degree of vital organ failures and the length of artificial ventilation. The mechanisms of insulins positive effects are not clear. The purpose of this research was to test the hypothesis that positive effect of intensive insulin treatment are related to blood flow in different organs including the forearm in artificially ventilated septic patients.
Ethics approval(s)	Ethical Committee at the Ministry of Health of Republic of Slovenia approved on the 14th May 2002 (ref: 88/05/02)
Health condition(s) or problem(s) studied	Mechanical ventilation due to acute respiratory failure
Intervention	Patients were randomised into two groups as regards the regulation of blood glucose: intensive (Group 1) and standard (Group 2). In the standard protocol the serum glucose concentration was maintained within the range of 7.0 - 11.0 mmol/l while in the intensive protocol the concentration was maintained within the range of 4.4 - 6.1 mmol/l. In a 50 ml syringe, 50 IE of human insulin for intravenous administration was diluted in a 0.9% solution of sodium chloride. The amount of infusion was adjusted according to the values of serum glucose concentrations according to a study published by Brown and Dodek (2001). The serum glucose concentration was determined with the hexokinase method hourly at the beginning of insulin treatment and every 2 hours thereafter, except when the dose of insulin was adjusted. In this case, the next measurement was taken after 1 hour. The treatment was initiated within 48 hours from the start of artificial ventilation. Up to that point, the serum glucose concentrations were maintained in the 8.8 - 11.0 mmol/l range by means of subcutaneous administration of rapid-acting insulin or the above described infusion. Blood glucose levels were maintained according to different protocols for 72 hours from the start of the trial.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Insulin
Primary outcome measure(s)	1. Measurements of forearm flow, performed by means of a plethysmograph (model EC5R, D.E. Hokanson, Inc., USA). In brief outline: the patient was in a supine position with the upper body lifted by approximately 150 cm. The forearm was positioned in the level of the right atrium (at 3/5 chest height). A 10 cm wide cuff was placed on the forearm and connected to the rapid cuff inflator. A mercury-filled clamp with a circumference 1.5 - 2 cm smaller than the forearm circumference was placed on the widest part of the forearm. A second, 8 cm wide cuff was placed just above the wrist in order to block arterial inflow to the thermoregulatory area, in our case the hand. The upper arm cuff pressure was preset to 50 mmHg. After 10 seconds of inflation the cuff was deflated for 5 seconds. Prior to the measurement, the wrist cuff was inflated to the value 40 mmHg above the systolic pressure for the duration of a single measurement (approximately 1 minute). The plethysmographic curve was recorded and measurement was repeated every 10 minutes, and each individual measurement lasted 1 hour. 2. Instantaneous arterial flow, calculated manually by analysing the average value of three plethysmographic recordings 3. Values of instantaneous arterial flow, expressed as ml/100 ml of tissue/min. To estimate the total forearm flow the area under the 60-minute arterial flow curve was calculated. All arterial flow measurements were taken at the beginning of the study (t0), after 2 hours (t1), after 24 hours (t2) and after 72 hours (t3) between 8 am and 9 am, with the exception of insulin infusion measurements, which were taken between 11 am and 12 pm.
Key secondary outcome measure(s)	1. Duration of mechanical ventilation (days) 2. 30-day mortality rate
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key inclusion criteria	Critically ill mechanically ventilated patients of both sexes, aged 18 years and older, who meet following criteria: 1. Admission criteria for sepsis (at least two American College of Chest Physicians/Society of Critical Care Medicine [ACCP/SCCM] 1992 criteria) 2. Mechanical ventilation due to acute respiratory failure 3. No prior data of diabetes mellitus 4. Start of the trial up to 48 hours after admission
Key exclusion criteria	1. Aged below 18 years 2. Pregnancy 3. Terminal neoplastic disease 4. Known diabetes mellitus 5. Mechanical ventilation due to due to primary failure of respiratory muscles 6. Mechanical ventilation due to brain injury
Date of first enrolment	01/01/2005
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Slovenia

Study participating centre

General Hospital Celje

Celje
3000
Slovenia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes