Effect of High volumeHemodiafiltration on Lung Oxygenation

NCT ID: NCT03853005

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2020-11-10

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.

Conditions

Haemofiltration; Lung Mechanics; Septic Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (controlled group)

They will not receive HVHDF treatment

Group Type: PLACEBO_COMPARATOR

controlled

Intervention Type: OTHER

Patients will receive the usual care

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.

Group Type: ACTIVE_COMPARATOR

HVHDF

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

controlled

Patients will receive the usual care

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Abd El-Khalek Mohammed Glala

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Assiut university A Egypt

Role: STUDY_DIRECTOR

Assiut University

Locations

Faculty of medicine - Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

28503011700371A1

Identifier Type: -

Identifier Source: org_study_id