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Completed

NCT Number: NCT03853005

Effect of High volumeHemodiafiltration on Lung Oxygenation

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine - Assiut university

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • 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
  • 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

  • Patient relatives' refusal
  • Pregnancy
  • Recent active internal hemorrhage
  • Not mechanically ventilated.
  • Hypersensitivity to the dialyser fluid

Treatment and study plan

HVHDF

Other

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.

Controlled

Other

Patients will receive the usual care

Primary outcomes

  1. Arterial oxygen pressure (PaO2)

    Time frame: 24 hours after start of HVHDF

    Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg)

Secondary outcomes

  1. 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

    Changes in the ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio)

  2. Ventilatory function

    Time frame: 0 hour, 24 hours, and 48 hours after start of HVHDF

    Changes in compliance (ml/cmH2O)

  3. The duration for weaning from mechanical ventilation (MV)

    Time frame: 28 days

    Days until weaning the patient from mechanical ventilation (MV)

Other outcomes

  1. Interleukin-6

    Time frame: 0 hour, 24 hours, and 48 hours after start of HVHDF

    Changes in Interleukin-6 (ng/dL)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2019
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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