An interventional study of HVHDF and controlled in Haemofiltration, Lung Mechanics and Septic Patients, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Severe sepsis defined by Quick SOFA score by presentation of 2 or more of the following criteria:
Organ dysfunctions are defined as following:
Respiratory dysfunction (criteria for ARDS):
CNS failure:
CVS dysfunction:
Liver dysfunction:
Renal dysfunction:
Bone marrow depression:
Exclusion Criteria:
They will not receive HVHDF treatment
Other: controlled
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.
Other: HVHDF
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.
Patients will receive the usual care
Arterial oxygen pressure (PaO2)
Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg)
Time frame: 24 hours after start of HVHDF
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)
Time frame: 0 hour, 24 hours, and 48 hours after start of HVHDF
Ventilatory function
Changes in compliance (ml/cmH2O)
Time frame: 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)
Time frame: 28 days
Interleukin-6
Changes in Interleukin-6 (ng/dL)
Time frame: 0 hour, 24 hours, and 48 hours after start of HVHDF
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Assiut University