Effect of High volumeHemodiafiltration on Lung Oxygenation

NCT03853005 | Completed DMC

• 1 other identifier: 28503011700371A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Haemofiltration; Lung Mechanics; Septic Patients

Outcome Measures

Primary Outcomes (1)

• Arterial oxygen pressure (PaO2)

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

  24 hours after start of HVHDF

Secondary Outcomes (3)

• 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

  0 hour, 24 hours, and 48 hours after start of HVHDF

• The duration for weaning from mechanical ventilation (MV)

  28 days

Other Outcomes (1)

• Interleukin-6

  0 hour, 24 hours, and 48 hours after start of HVHDF

Study Arms (2)

Group A (controlled group)

PLACEBO COMPARATOR

They will not receive HVHDF treatment

Other: controlled

Group B (HVHDF group)

ACTIVE COMPARATOR

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

Interventions

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.

Group B (HVHDF group)

controlled OTHER

Patients will receive the usual care

Group A (controlled group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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:

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine - Assiut university

Asyut, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Assiut university A Egypt

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ayman Abd ELkhalek Mohammed, lecturer, clinical anesthesiologist and principal investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: February 25, 2019
• Study Start: March 20, 2019
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

EG (1)