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Ketanest In Septic Shock

Ketanest In Septic Shock - KISS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32350
Enrollment
20
Registered
2008-12-31
Start date
2008-12-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

ernstig zieke intensive care patienten sepsis

Interventions

Patients accepted for this study are randomised to either the ketanest (K) or etomidate (E) group. The primary objective in patients with septic shock is restoration of adequate tissue perfusion. Th

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. fullfilling SIRS criteria with a supposed infectious cause, 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. ventilatory and oxygen delivery variables Airway pressures / FiO2 / tidal volume / Arterial blood analysis / 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)