Effect of High volumeHemodiafiltration on Lung Oxygenation

Assiut University

Status: Completed

Conditions: Septic Patients; Haemofiltration; Lung Mechanics

Treatments: Other: controlled; Other: HVHDF

Study type: Interventional

Funder types: Other

Identifiers

NCT03853005

28503011700371A1

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Group A (controlled group)

Placebo Comparator group

Description:

They will not receive HVHDF treatment

Treatment:

Other: controlled

Group B (HVHDF group)

Active Comparator group

Description:

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.

Treatment:

Other: HVHDF