Haemofiltration, Lung Mechanics, Septic Patients
Conditions
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.
Interventions
OTHERHVHDF
Patients will receive HVHDF treatment for 48 hours. HVHDF will be performed via indwelling central venous catheter. The blood flow will be 180-240 ml/min, and ultrafiltration rate will be 70 ml/kg/h during HVHF. The substitute fluid will be infused with pre-dilution. Heparin will be used for anti-coagulation, whose initial dose will be 15-25 U/kg, and maintenance dose is 5-15 U/kg/h. aPTT time maintained between 60-80 second and will be checked every 12 hours.
OTHERcontrolled
Patients will receive the usual care
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial oxygen pressure (PaO2) | 24 hours after start of HVHDF | Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio) | 0 hour, 24 hours, and 48 hours after start of HVHDF | Changes in the ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio) |
| Ventilatory function | 0 hour, 24 hours, and 48 hours after start of HVHDF | Changes in compliance (ml/cmH2O) |
| The duration for weaning from mechanical ventilation (MV) | 28 days | Days until weaning the patient from mechanical ventilation (MV) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 | 0 hour, 24 hours, and 48 hours after start of HVHDF | Changes in Interleukin-6 (ng/dL) |
Countries
Egypt
Outcome results
None listed