Effect of High volumeHemodiafiltration on Lung Oxygenation and Mechanics

Lung Mechanics Clinical Trial

Official title:

Effect of High Volume Hemodiafiltration on Lung Oxygenation, Lung Mechanics and Biomarkers in Mechanically Ventilated Patients With Severe Sepsis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03853005
• Other study ID #: 28503011700371A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: April 28, 2019

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: Ayman A Glala, Ass.lecturer
• Phone: 00201025675901
• Email: Aymanglala24[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate improvement of sepsis patients with a new modality of treatment (HDF)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 28, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemofiltration
• Lung Mechanics
• Septic Patients

Intervention

Other:
• HVHDF
Patients will receive HVHDF treatment for at least 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 35-50 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.
• controlled
supportive care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial oxygen pressure	change in arterial oxygen pressure (PO2) in units of millimeter mercury (mmHg)	at 0 hour, 24hours and after completion of 48 hours
Secondary	lung mechanics	change in compliance (ml/cmH2O)	0, 24, and 48 hours
Secondary	inflammatory biomarkers	Measure inflammatory biomarkers: Interleukin-6.	0, 24, and 48 hours