Ketanest in septic shock.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28809

Enrollment

Registered

2009-02-16

Start date

2009-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Patients in need for intubation in early septic shock.

Interventions

Investigational treatment. Patients accepted for this study are randomised to either the ketanest (K) or etomidate (E) group. The only a priori difference in treatment will be the induction and maint

Eligibility

Inclusion criteria

Inclusion criteria: 1. Septic shock (see below); 2. In need for ventilatory support; 3. To be intubated on the ICU.

Exclusion criteria

Exclusion criteria: 1. 80 years old; 2. Symptomatic coronary artery disease; 3. Due to have surgery within 4 hours; 4. Already on corticosteroid therapy; 5. Pregnancy; 6. Pulmonary hypertension; 7. Preterminal illness.

Design outcomes

Primary

Measure	Time frame
These variables are measured every hour during the first 8 hours. However, these variables will be measured every 10 minutes during: 1. The two hour following the induction of anesthesia (0-2h); 2. The two hour after the switch to midazolam/fentanyl anesthesia (2-4). 1. CVP (10 min average); 2. HR/BP (10 min average); 3. MAP (10 min average); 4. Urine output (60 min average); 5. ScvO2 and arterial blood analysis (every 30 minutes); 6. Resuscitation volume (specific sum); 7. Inotropic support (value of rate and cumulative dose); 8. Vasopressor support (value of rate and cumulative dose).	—

Measure

Time frame

These variables are measured every hour during the first 8 hours. However, these variables will be measured every 10 minutes during: 1. The two hour following the induction of anesthesia (0-2h); 2. The two hour after the switch to midazolam/fentanyl anesthesia (2-4). 1. CVP (10 min average); 2. HR/BP (10 min average); 3. MAP (10 min average); 4. Urine output (60 min average); 5. ScvO2 and arterial blood analysis (every 30 minutes); 6. Resuscitation volume (specific sum); 7. Inotropic support (value of rate and cumulative dose); 8. Vasopressor support (value of rate and cumulative dose).

—

Secondary

Measure	Time frame
1. Ventilatory and oxygen delivery variables: Airway pressures / FiO2 / tidal volume / Lactate /Hb, are measured every hour during the first 4 hours, and after 8 hours; 2. Adverse psychological reactions: During the observation period, checking the medical record upto 24 hours after induction, and, if possible, asking the patient for adverse psychological effects as soon as possible after awaking and after extubation; 3. Adrenal gland responsiveness: Before induction: basal serum total cortisol, free cortisol, and 11beta-deoxycortisol At 6 and 24 hrs after induction of anesthesia: basal serum total cortisol, free cortisol, and 11beta-deoxycortisol followed by a standard high dose (250 ug of synthetic ACTH) Synacthentest, with measurements of total, free cortisol and 11-beta deoxycortisol at 0, 30 and 60 minutes; 4. Inflammatory markers: Baseline, 6 and 24 hours: IL6, TNFa.	—

Measure

Time frame

1. Ventilatory and oxygen delivery variables: Airway pressures / FiO2 / tidal volume / Lactate /Hb, are measured every hour during the first 4 hours, and after 8 hours; 2. Adverse psychological reactions: During the observation period, checking the medical record upto 24 hours after induction, and, if possible, asking the patient for adverse psychological effects as soon as possible after awaking and after extubation; 3. Adrenal gland responsiveness: Before induction: basal serum total cortisol, free cortisol, and 11beta-deoxycortisol At 6 and 24 hrs after induction of anesthesia: basal serum total cortisol, free cortisol, and 11beta-deoxycortisol followed by a standard high dose (250 ug of synthetic ACTH) Synacthentest, with measurements of total, free cortisol and 11-beta deoxycortisol at 0, 30 and 60 minutes; 4. Inflammatory markers: Baseline, 6 and 24 hours: IL6, TNFa.

—

Contacts

Public ContactS. Houtman

S.Houtman@cwz.nl+31 (0)644634048

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)