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

Intensive insulin treatment in critically ill patients and forearm blood flow: a randomised parallel group trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39026810

Enrollment

Registered

2009-07-29

Start date

2005-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical ventilation due to acute respiratory failure Respiratory Respiratory failure, not elsewhere classified

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
1. Duration of mechanical ventilation (days) 2. 30-day mortality rate	—

Countries

Slovenia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026