Effect of High volumeHemodiafiltration on Lung Oxygenation

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

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

Study Overview

• Status: Completed
• Conditions: Haemofiltration; Lung Mechanics; Septic Patients
• Intervention / Treatment: Other: controlled; Other: HVHDF

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of Medicine - Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A (controlled group); They will not receive HVHDF treatment	Other: controlled; Patients will receive the usual care
Active Comparator: Group B (HVHDF group); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-6	Changes in Interleukin-6 (ng/dL)	0 hour, 24 hours, and 48 hours after start of HVHDF

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Assiut university A Egypt, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 28503011700371A1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No