Effect of High volumeHemodiafiltration on Lung Oxygenation

Not Applicable

Completed

• Conditions: Haemofiltration; Septic Patients; Lung Mechanics
• Interventions: Other: HVHDF; Other: controlled

• Registration Number: NCT03853005
• Lead Sponsor: Assiut University

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 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.

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Study Start: 2019-03-20
• Primary Completion: 2020-11-10
• Study Completion: 2020-11-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (HVHDF group)	HVHDF	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.
Group A (controlled group)	controlled	They will not receive HVHDF treatment

Primary Outcome Measures

Name	Time	Method
Arterial oxygen pressure (PaO2)	24 hours after start of HVHDF	Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg)

Secondary Outcome Measures

Name	Time	Method
Ventilatory function	0 hour, 24 hours, and 48 hours after start of HVHDF	Changes in compliance (ml/cmH2O)
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	Changes in the ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio)
The duration for weaning from mechanical ventilation (MV)	28 days	Days until weaning the patient from mechanical ventilation (MV)

Trial Locations

Locations (1)

Faculty of medicine - Assiut university; 🇪🇬 Assiut, Egypt