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High volume hemodiafiltration (HVHDF) has been used in septic patients to get hemodynamic improvement and possibly survival benefit.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (controlled group) | Placebo Comparator | They will not receive HVHDF treatment |
|
| Group B (HVHDF group) | Active Comparator | They 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. The survival status of all of the subjects were followed up at 28 days after being diagnosed as severe sepsis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVHDF | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial oxygen pressure (PaO2) | Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg) | 24 hours after start of HVHDF |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio) | Changes in 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 |
| Ventilatory function |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 | Changes in Interleukin-6 (ng/dL) | 0 hour, 24 hours, and 48 hours after start of HVHDF |
Inclusion Criteria:
≥ 18 years
Severe sepsis defined by Quick SOFA score by presentation of 2 or more of the following criteria:
Organs dysfunction (including one of them respiratory failure).
Organ dysfunctions are defined as following:
Respiratory dysfunction (criteria for ARDS):
CNS failure:
CVS dysfunction:
Liver dysfunction:
Renal dysfunction:
Bone marrow depression:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Assiut university A Egypt | Assiut University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine - Assiut university | Asyut | Egypt |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| controlled | Other | Patients will receive the usual care |
|
Changes in compliance (ml/cmH2O) |
| 0 hour, 24 hours, and 48 hours after start of HVHDF |
| The duration for weaning from mechanical ventilation (MV) | Days until weaning the patient from mechanical ventilation (MV) | 28 days |
| D008722 | Methods |