HaemofiltrationNCT03853005
Effect of High volumeHemodiafiltration on Lung Oxygenation
A study testing HVHDF in people with Haemofiltration and Lung Mechanics, run by Assiut University at 1 site in Egypt.
Trial summary
High volume hemodiafiltration (HVHDF) has been used in septic patients to get hemodynamic improvement and possibly survival benefit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Haemofiltration, Lung Mechanics, Septic Patients
- What is being tested?
- HVHDF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2019to 10 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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).
Show all 33Show fewer
- 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
Who cannot join
- Patient relatives' refusal
- Pregnancy
- Recent active internal hemorrhage
- Not mechanically ventilated.
- Hypersensitivity to the dialyser fluid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- HVHDF, controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVHDFOther
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.
controlledOther
Patients will receive the usual care
| Study group | Role | What they receive |
|---|---|---|
| Group A (controlled group) | Placebo comparator | They will not receive HVHDF treatment Receives: 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. Receives: Other: HVHDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen pressure (PaO2)
Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg)
Measured: 24 hours after start of HVHDF
Secondary outcomes (3)
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)
Measured: 0 hour, 24 hours, and 48 hours after start of HVHDF
Ventilatory function
Changes in compliance (ml/cmH2O)
Measured: 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)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start20 Mar 2019
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemofiltrationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abd El-Khalek Mohammed Glala, Assiut University
- Investigators
- Assiut university A Egypt, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853005
- Sponsor's protocol ID
- 28503011700371A1
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2018
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Volume Hemodiafiltration on Lung Oxygenation, Lung Mechanics and Biomarkers in Mechanically Ventilated Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT03853005
- Acronym / sponsor ID
- 28503011700371A1
- Conditions
- Haemofiltration, Lung Mechanics, Septic Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (controlled group) | Placebo comparator | Other: controlledThey will not receive HVHDF treatment |
| Group B (HVHDF group) | Active comparator | Other: HVHDFThey 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- ≥ 18 years
- Severe sepsis defined by Quick SOFA score by presentation of 2 or more of the following criteria:
- Organs dysfunction (including one of them respiratory failure).
- PaO2/FiO2 <200
- Bilateral infiltrates in chest X-ray
Key exclusion criteria (5 listed)
- Patient relatives' refusal
- Pregnancy
- Recent active internal hemorrhage
- Not mechanically ventilated.
- Hypersensitivity to the dialyser fluid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HVHDFPatients 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. | Other | Group B (HVHDF group) |
| controlledPatients will receive the usual care | Other | Group A (controlled group) |
Primary outcome
Arterial oxygen pressure (PaO2)
Time frame: 24 hours after start of HVHDF
Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg)
3 secondary outcomes
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
Ventilatory function
Time frame: 0 hour, 24 hours, and 48 hours after start of HVHDF
The duration for weaning from mechanical ventilation (MV)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assiut university A Egypt study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HVHDF in people with Haemofiltration and Lung Mechanics, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygen pressure (PaO2) (time frame: 24 hours after start of HVHDF). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.