Clinical trial NCT03853005: Effect of High volumeHemodiafiltration on Lung Oxygenation
Official title: Effect of High Volume Hemodiafiltration on Lung Oxygenation, Lung Mechanics and Biomarkers in Mechanically Ventilated Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemofiltration
Lung Mechanics
Septic Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High volume hemodiafiltration (HVHDF) has been used in septic patients to get hemodynamic improvement and possibly survival benefit.

Detailed description: Sepsis, defined as life-threatening organ dysfunction caused by dysregulated immune response to infection. Hemofiltration has been suggested as beneficial in restoring immune homeostasis. High volume hemodiafiltration (HVHDF) is a hybrid method of intermittent renal replacement therapy (RRT), where high filtration volumes are applied. In several studies; higher filtration volumes have been shown to achieve hemodynamic improvement and possibly survival benefit in patients with septic shock.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years
2. Severe sepsis defined by Quick SOFA score by presentation of 2 or more of the following criteria:

   * Mental clouding: decreased glasco coma scale GCS \< 15
   * Hypotension: Systolic blood pressure \< 100 mmgH
   * Tachypnea: respiratory rate \> 22 breath/ minute Then serum lactate is analysed to confirm sepsis hypoperfusion if ≥ 2mmol/L
3. Organs dysfunction (including one of them respiratory failure).

Organ dysfunctions are defined as following:

Respiratory dysfunction (criteria for ARDS):

* PaO2/FiO2 \<200
* Bilateral infiltrates in chest X-ray
* Resistant hypoxemia
* Tachypnoea (RR \> 40 breath/minute)
* The need for invasive mechanical ventilation
* Excluded cardiac causes of pulmonary edema

CNS failure:

* Decreased GCS ≥ 4 decreased points

CVS dysfunction:

* Sustained hypotension even on very high inotropes doses (Noradrenaline \>1µm/min)+ adrenaline\>1.5µm/min associated
* with high CVP pressure \> 12 mmHg and not responding to fluid challenge test to exclude hypovolemia.
* Cardiomegaly detected by either echocardiography assessment, or chest X-ray
* Resistant frequent ventricular ectopics not explained by organic causes.

Liver dysfunction:

* Elevated total and direct bilirubin than double normal or basal levels
* Elevated prothrombin time \> 17 seconds or INR \> 1.5
* Elevated liver enzymes \> triple normal level

Renal dysfunction:

* Decreased urine output \< 0.5 ml/kg.
* Elevated creatinine level \> 164 µmol/L (1.5mg/dL).
* Decreased creatinine clearance \<50ml/minute if available.

Bone marrow depression:

* Decreased platelets \< 90 X 103/µL
* Decreased leukocytes \<4 X 103/µL
* Decreased RBCs count \< 4 X 106/µL

Exclusion Criteria:

1. Patient relatives' refusal
2. Pregnancy
3. Recent active internal hemorrhage
4. Not mechanically ventilated.
5. Hypersensitivity to the dialyser fluid

Primary outcomes:
measure: Arterial oxygen pressure (PaO2)
timeFrame: 24 hours after start of HVHDF
Secondary outcomes:
measure: The ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio)
timeFrame: 0 hour, 24 hours, and 48 hours after start of HVHDF
measure: Ventilatory function
timeFrame: 0 hour, 24 hours, and 48 hours after start of HVHDF
measure: The duration for weaning from mechanical ventilation (MV)
timeFrame: 28 days
Other outcomes:
measure: Interleukin-6
timeFrame: 0 hour, 24 hours, and 48 hours after start of HVHDF
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine - Assiut university
Study officials:
affiliation: Assiut University
name: Assiut university A Egypt
role: STUDY_DIRECTOR
References: