Status:
COMPLETED
Effect of High volumeHemodiafiltration on Lung Oxygenation
Lead Sponsor:
Assiut University
Conditions:
Haemofiltration
Lung Mechanics
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- ≥ 18 years
- 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
- 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
- Patient relatives' refusal
- Pregnancy
- Recent active internal hemorrhage
- Not mechanically ventilated.
- Hypersensitivity to the dialyser fluid
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03853005
Start Date
March 20 2019
End Date
November 10 2020
Last Update
August 19 2024
Active Locations (1)
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1
Faculty of medicine - Assiut university
Asyut, Egypt