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Clinical Trials/NCT03853005
NCT03853005CompletedNot Applicable

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

Assiut University2 sites in 1 country40 target enrollmentStarted: March 20, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Arterial oxygen pressure (PaO2)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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
  • •Recent active internal hemorrhage
  • •Not mechanically ventilated.
  • •Hypersensitivity to the dialyser fluid

Outcomes

Primary Outcomes

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

  • Ventilatory function(0 hour, 24 hours, and 48 hours after start of HVHDF)
  • 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)
  • The duration for weaning from mechanical ventilation (MV)(28 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ayman Abd El-Khalek Mohammed Glala

Ayman Abd ELkhalek Mohammed, lecturer, clinical anesthesiologist and principal investigator

Assiut University

Study Sites (2)

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