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Ketanest in septic shock.

Recruiting
Conditions
Patients in need for intubation in early septic shock.
Registration Number
NL-OMON28809
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

1. Septic shock (see below);

2. In need for ventilatory support;

Exclusion Criteria

1. <18 and >80 years old;

2. Symptomatic coronary artery disease;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
These variables are measured every hour during the first 8 hours. However, these variables will be measured every 10 minutes during:<br /><br>1. The two hour following the induction of anesthesia (0-2h);<br /> <br>2. The two hour after the switch to midazolam/fentanyl anesthesia (2-4).<br><br /><br /><br>1. CVP (10 min average);<br /><br>2. HR/BP (10 min average);<br /><br>3. MAP (10 min average);<br /><br>4. Urine output (60 min average);<br /><br>5. ScvO2 and arterial blood analysis (every 30 minutes);<br /><br>6. Resuscitation volume (specific sum);<br /><br>7. Inotropic support (value of rate and cumulative dose);<br /><br>8. Vasopressor support (value of rate and cumulative dose).<br>
Secondary Outcome Measures
NameTimeMethod
1. Ventilatory and oxygen delivery variables:<br>Airway pressures / FiO2 / tidal volume / Lactate /Hb, are measured every hour during the first 4 hours, and after 8 hours;<br /><br><br>2. Adverse psychological reactions:<br>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;<br /><br><br>3. Adrenal gland responsiveness:<br>Before induction: basal serum total cortisol, free cortisol, and 11beta-deoxycortisol<br>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;<br /> <br><br>4. Inflammatory markers: <br>Baseline, 6 and 24 hours: IL6, TNFa. <br>
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