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                    <a href="?cresstrial=2811&amp;modal=1&amp;valnames=exclusion_criteria&amp;order=created_at">Created at</a>
                </th>
                <th scope="col">Source</th>
                
                <th scope="col">Raw Value</th>
                <th scope="col">Validated value</th>
            </tr>
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            <tr class="histvalue-row" histvalueid="500944" class="table-">
                
                <td>June 25, 2024, noon</td>
                <td>usa</td>
                
                <td class="histvalue-container">
                    

        <p class="exclusion_criteria">
            * persistent septic shock (\&gt;24h) with a mean arterial pressure (map) ≤ 65 mm hg and serum lactate level \&gt; 4 mmol/l (36 mg/dl) despite adequate volume resuscitation and vasopressor use (norepinephrine \&gt; 0.2 μg/kg/min) for \&gt; 6 hours;
* pre-existing chronic pulmonary disease, including:

  * known diagnosis of interstitial lung disease
  * known diagnosis of copd gold stage iv or fev1\&lt;30% predicted
  * dlco \&lt;45% (if test results are available)
  * total lung capacity (tlc) \&lt; 60% of predicted (if test results are available);
* chronic home oxygen treatment;
* pre-existing heart failure with a known left ventricular ejection fraction \&lt;40%;
* active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year;
* currently receiving extracorporeal life support (ecls);
* severe chronic liver disease with child-pugh score \&gt; 12;
* subjects in whom a decision to withdraw medical care is made (e.g. palliative setting);
* inability of the icu staff to initiate imp administration within 48 hours of intubation;
* known to be pregnant or breast-feeding;
* enrolled in a concomitant clinical trial of an investigational medicinal product;
* white blood count \&lt; 2.5x109/l;
* haemoglobin \&lt; 4.0 mmol/l;
* thrombocytes \&lt; 50x109/l;
* the use of strong cyp3a4 inducers, including the following drugs:

  * carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;
        </p>
    

                </td>
                <td class="histvalue-container">
                    

        <p class="exclusion_criteria validated">
            * persistent septic shock (\&gt;24h) with a mean arterial pressure (map) ≤ 65 mm hg and serum lactate level \&gt; 4 mmol/l (36 mg/dl) despite adequate volume resuscitation and vasopressor use (norepinephrine \&gt; 0.2 μg/kg/min) for \&gt; 6 hours;
* pre-existing chronic pulmonary disease, including:

  * known diagnosis of interstitial lung disease
  * known diagnosis of copd gold stage iv or fev1\&lt;30% predicted
  * dlco \&lt;45% (if test results are available)
  * total lung capacity (tlc) \&lt; 60% of predicted (if test results are available);
* chronic home oxygen treatment;
* pre-existing heart failure with a known left ventricular ejection fraction \&lt;40%;
* active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year;
* currently receiving extracorporeal life support (ecls);
* severe chronic liver disease with child-pugh score \&gt; 12;
* subjects in whom a decision to withdraw medical care is made (e.g. palliative setting);
* inability of the icu staff to initiate imp administration within 48 hours of intubation;
* known to be pregnant or breast-feeding;
* enrolled in a concomitant clinical trial of an investigational medicinal product;
* white blood count \&lt; 2.5x109/l;
* haemoglobin \&lt; 4.0 mmol/l;
* thrombocytes \&lt; 50x109/l;
* the use of strong cyp3a4 inducers, including the following drugs:

  * carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;
        </p>
        
    
                </td>
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            <tr class="histvalue-row" histvalueid="98889" class="table-">
                
                <td>March 13, 2021, 12:31 a.m.</td>
                <td>usa</td>
                
                <td class="histvalue-container">
                    

        <p class="exclusion_criteria">
            -  persistent septic shock (&gt;24h) with a mean arterial pressure (map) ≤ 65 mm hg and
             serum lactate level &gt; 4 mmol/l (36 mg/dl) despite adequate volume resuscitation and
             vasopressor use (norepinephrine &gt; 0.2 μg/kg/min) for &gt; 6 hours;

          -  pre-existing chronic pulmonary disease, including:

               -  known diagnosis of interstitial lung disease

               -  known diagnosis of copd gold stage iv or fev1&lt;30% predicted

               -  dlco &lt;45% (if test results are available)

               -  total lung capacity (tlc) &lt; 60% of predicted (if test results are available);

          -  chronic home oxygen treatment;

          -  pre-existing heart failure with a known left ventricular ejection fraction &lt;40%;

          -  active treatment of haematological or non-haematological cancer with targeted immuno-
             or chemotherapy, or thoracic radiotherapy in the last year;

          -  currently receiving extracorporeal life support (ecls);

          -  severe chronic liver disease with child-pugh score &gt; 12;

          -  subjects in whom a decision to withdraw medical care is made (e.g. palliative
             setting);

          -  inability of the icu staff to initiate imp administration within 48 hours of
             intubation;

          -  known to be pregnant or breast-feeding;

          -  enrolled in a concomitant clinical trial of an investigational medicinal product;

          -  white blood count &lt; 2.5x109/l;

          -  haemoglobin &lt; 4.0 mmol/l;

          -  thrombocytes &lt; 50x109/l;

          -  the use of strong cyp3a4 inducers, including the following drugs:

               -  carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum,
                  mitotaan, nevirapine, primidon, rifabutine, rifampicine;
        </p>
    

                </td>
                <td class="histvalue-container">
                    

        <p class="exclusion_criteria validated">
            -  persistent septic shock (&gt;24h) with a mean arterial pressure (map) ≤ 65 mm hg and
             serum lactate level &gt; 4 mmol/l (36 mg/dl) despite adequate volume resuscitation and
             vasopressor use (norepinephrine &gt; 0.2 μg/kg/min) for &gt; 6 hours;

          -  pre-existing chronic pulmonary disease, including:

               -  known diagnosis of interstitial lung disease

               -  known diagnosis of copd gold stage iv or fev1&lt;30% predicted

               -  dlco &lt;45% (if test results are available)

               -  total lung capacity (tlc) &lt; 60% of predicted (if test results are available);

          -  chronic home oxygen treatment;

          -  pre-existing heart failure with a known left ventricular ejection fraction &lt;40%;

          -  active treatment of haematological or non-haematological cancer with targeted immuno-
             or chemotherapy, or thoracic radiotherapy in the last year;

          -  currently receiving extracorporeal life support (ecls);

          -  severe chronic liver disease with child-pugh score &gt; 12;

          -  subjects in whom a decision to withdraw medical care is made (e.g. palliative
             setting);

          -  inability of the icu staff to initiate imp administration within 48 hours of
             intubation;

          -  known to be pregnant or breast-feeding;

          -  enrolled in a concomitant clinical trial of an investigational medicinal product;

          -  white blood count &lt; 2.5x109/l;

          -  haemoglobin &lt; 4.0 mmol/l;

          -  thrombocytes &lt; 50x109/l;

          -  the use of strong cyp3a4 inducers, including the following drugs:

               -  carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum,
                  mitotaan, nevirapine, primidon, rifabutine, rifampicine;
        </p>
        
    
                </td>
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Created at	Source	Raw Value	Validated value
June 25, 2024, noon	usa	* persistent septic shock (\>24h) with a mean arterial pressure (map) ≤ 65 mm hg and serum lactate level \> 4 mmol/l (36 mg/dl) despite adequate volume resuscitation and vasopressor use (norepinephrine \> 0.2 μg/kg/min) for \> 6 hours; * pre-existing chronic pulmonary disease, including: * known diagnosis of interstitial lung disease * known diagnosis of copd gold stage iv or fev1\<30% predicted * dlco \<45% (if test results are available) * total lung capacity (tlc) \< 60% of predicted (if test results are available); * chronic home oxygen treatment; * pre-existing heart failure with a known left ventricular ejection fraction \<40%; * active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year; * currently receiving extracorporeal life support (ecls); * severe chronic liver disease with child-pugh score \> 12; * subjects in whom a decision to withdraw medical care is made (e.g. palliative setting); * inability of the icu staff to initiate imp administration within 48 hours of intubation; * known to be pregnant or breast-feeding; * enrolled in a concomitant clinical trial of an investigational medicinal product; * white blood count \< 2.5x109/l; * haemoglobin \< 4.0 mmol/l; * thrombocytes \< 50x109/l; * the use of strong cyp3a4 inducers, including the following drugs: * carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;	* persistent septic shock (\>24h) with a mean arterial pressure (map) ≤ 65 mm hg and serum lactate level \> 4 mmol/l (36 mg/dl) despite adequate volume resuscitation and vasopressor use (norepinephrine \> 0.2 μg/kg/min) for \> 6 hours; * pre-existing chronic pulmonary disease, including: * known diagnosis of interstitial lung disease * known diagnosis of copd gold stage iv or fev1\<30% predicted * dlco \<45% (if test results are available) * total lung capacity (tlc) \< 60% of predicted (if test results are available); * chronic home oxygen treatment; * pre-existing heart failure with a known left ventricular ejection fraction \<40%; * active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year; * currently receiving extracorporeal life support (ecls); * severe chronic liver disease with child-pugh score \> 12; * subjects in whom a decision to withdraw medical care is made (e.g. palliative setting); * inability of the icu staff to initiate imp administration within 48 hours of intubation; * known to be pregnant or breast-feeding; * enrolled in a concomitant clinical trial of an investigational medicinal product; * white blood count \< 2.5x109/l; * haemoglobin \< 4.0 mmol/l; * thrombocytes \< 50x109/l; * the use of strong cyp3a4 inducers, including the following drugs: * carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;
March 13, 2021, 12:31 a.m.	usa	- persistent septic shock (>24h) with a mean arterial pressure (map) ≤ 65 mm hg and serum lactate level > 4 mmol/l (36 mg/dl) despite adequate volume resuscitation and vasopressor use (norepinephrine > 0.2 μg/kg/min) for > 6 hours; - pre-existing chronic pulmonary disease, including: - known diagnosis of interstitial lung disease - known diagnosis of copd gold stage iv or fev1<30% predicted - dlco <45% (if test results are available) - total lung capacity (tlc) < 60% of predicted (if test results are available); - chronic home oxygen treatment; - pre-existing heart failure with a known left ventricular ejection fraction <40%; - active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year; - currently receiving extracorporeal life support (ecls); - severe chronic liver disease with child-pugh score > 12; - subjects in whom a decision to withdraw medical care is made (e.g. palliative setting); - inability of the icu staff to initiate imp administration within 48 hours of intubation; - known to be pregnant or breast-feeding; - enrolled in a concomitant clinical trial of an investigational medicinal product; - white blood count < 2.5x109/l; - haemoglobin < 4.0 mmol/l; - thrombocytes < 50x109/l; - the use of strong cyp3a4 inducers, including the following drugs: - carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;	- persistent septic shock (>24h) with a mean arterial pressure (map) ≤ 65 mm hg and serum lactate level > 4 mmol/l (36 mg/dl) despite adequate volume resuscitation and vasopressor use (norepinephrine > 0.2 μg/kg/min) for > 6 hours; - pre-existing chronic pulmonary disease, including: - known diagnosis of interstitial lung disease - known diagnosis of copd gold stage iv or fev1<30% predicted - dlco <45% (if test results are available) - total lung capacity (tlc) < 60% of predicted (if test results are available); - chronic home oxygen treatment; - pre-existing heart failure with a known left ventricular ejection fraction <40%; - active treatment of haematological or non-haematological cancer with targeted immuno- or chemotherapy, or thoracic radiotherapy in the last year; - currently receiving extracorporeal life support (ecls); - severe chronic liver disease with child-pugh score > 12; - subjects in whom a decision to withdraw medical care is made (e.g. palliative setting); - inability of the icu staff to initiate imp administration within 48 hours of intubation; - known to be pregnant or breast-feeding; - enrolled in a concomitant clinical trial of an investigational medicinal product; - white blood count < 2.5x109/l; - haemoglobin < 4.0 mmol/l; - thrombocytes < 50x109/l; - the use of strong cyp3a4 inducers, including the following drugs: - carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine;