Inflammatory ResponseNCT04014439
Relationship Between NLR and Prealbumin Levels With Diaphragm Thickness
An observational study of Inflammatory Response, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
A study to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Ratio of Neutrophil to Lymphocyte and Level of Prealbumin Serum
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2019to 1 Dec 2019
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are treated in intensive care unit and using mechanical ventilation from Day 0 till Day 5. These patients will be checked for their diaphragm thickness, level of prealbumin serums, and ratio of neutrophil to lymphocyte.
Who may be able to join
- Critical patients treated in intensive care unit using mechanical ventilation from day 0.
- Patients are clinically predicted to be treated for more than 5 days (qSOFA and clinical assessment)
Who cannot join
- History of suffering from neuromuscular disease and or diaphragmatic malformations
- Used non-invasive ventilation before starting to use mechanical ventilation
- History of tracheostomy
- Patients admitted to ICU within 12 months before this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Neutrophil to Lymphocyte Ratio and Prealbumin Serum Levels With Diaphragm Thickness in Critical Patients
A study to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.
Read the detailed description
Weaning from ventilator sometimes can be failed and it happened due to several factors. One of the causes was Ventilator Induced Diaphragm Dysfunction (VIDD). This VIDD process occurred due to thinning process of the diaphragm thickness or decreased diaphragm muscle mass. The whole process happened due to inflammatory reaction that usually appeared on patients in Intensive Care Unit (ICU). Thus, this study was aimed to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.
- Conditions
- Inflammatory Response
- Being tested
- Ratio of Neutrophil to Lymphocyte, Level of Prealbumin Serum
- Keywords
- diaphragm thickness, neutrophil to lymphocyte ratio, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ratio of Neutrophil to LymphocyteDiagnostic test
Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.
Level of Prealbumin SerumDiagnostic test
Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.
| Study group | Role | What they receive |
|---|---|---|
| Normal Diaphragm | Diaphragm thickness is 2 mm or more Receives: Diagnostic Test: Ratio of Neutrophil to Lymphocyte; Diagnostic Test: Level of Prealbumin Serum | |
| Thinning Diaphragm | Diaphragm thickness is less than 2 mm Receives: Diagnostic Test: Ratio of Neutrophil to Lymphocyte; Diagnostic Test: Level of Prealbumin Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Prealbumin Serum
Measured: 5 days
Ratio of Neutrophil to Lymphocyte
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudyanto Sedono, Universitas Indonesia
- Investigators
- Rudyanto Sedono, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014439
- Sponsor's protocol ID
- IndonesiaUAnes037
- Status last verified
- Dec 2019
- First submitted
- 8 Jul 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li C, Li X, Han H, Cui H, Wang G, Wang Z. Diaphragmatic ultrasonography for predicting ventilator weaning: A meta-analysis. Medicine (Baltimore). 2018 Jun;97(22):e10968. doi: 10.1097/MD.0000000000010968.
PubMed 29851847Flevari A, Lignos M, Konstantonis D, Armaganidis A. Diaphragmatic ultrasonography as an adjunct predictor tool of weaning success in patients with difficult and prolonged weaning. Minerva Anestesiol. 2016 Nov;82(11):1149-1157. Epub 2016 Jul 12.
PubMed 27407022Conti G, Montini L, Pennisi MA, Cavaliere F, Arcangeli A, Bocci MG, Proietti R, Antonelli M. A prospective, blinded evaluation of indexes proposed to predict weaning from mechanical ventilation. Intensive Care Med. 2004 May;30(5):830-6. doi: 10.1007/s00134-004-2230-8. Epub 2004 Mar 20.
PubMed 15127195Sellares J, Ferrer M, Cano E, Loureiro H, Valencia M, Torres A. Predictors of prolonged weaning and survival during ventilator weaning in a respiratory ICU. Intensive Care Med. 2011 May;37(5):775-84. doi: 10.1007/s00134-011-2179-3. Epub 2011 Mar 4.
PubMed 21373820Khan J, Harrison TB, Rich MM. Mechanisms of neuromuscular dysfunction in critical illness. Crit Care Clin. 2008 Jan;24(1):165-77, x. doi: 10.1016/j.ccc.2007.10.004.
PubMed 18241784
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Neutrophil to Lymphocyte Ratio and Prealbumin Serum Levels With Diaphragm Thickness in Critical Patients
- ClinicalTrials.gov ID
- NCT04014439
- Acronym / sponsor ID
- IndonesiaUAnes037
- Conditions
- Inflammatory Response
- Keywords
- diaphragm thickness, neutrophil to lymphocyte ratio, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Jul 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.
A study to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.
Detailed description
Weaning from ventilator sometimes can be failed and it happened due to several factors. One of the causes was Ventilator Induced Diaphragm Dysfunction (VIDD). This VIDD process occurred due to thinning process of the diaphragm thickness or decreased diaphragm muscle mass. The whole process happened due to inflammatory reaction that usually appeared on patients in Intensive Care Unit (ICU). Thus, this study was aimed to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Diaphragm | – | Diagnostic Test: Ratio of Neutrophil to Lymphocyte, Diagnostic Test: Level of Prealbumin SerumDiaphragm thickness is 2 mm or more |
| Thinning Diaphragm | – | Diagnostic Test: Ratio of Neutrophil to Lymphocyte, Diagnostic Test: Level of Prealbumin SerumDiaphragm thickness is less than 2 mm |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are treated in intensive care unit and using mechanical ventilation from Day 0 till Day 5. These patients will be checked for their diaphragm thickness, level of prealbumin serums, and ratio of neutrophil to lymphocyte.
Key inclusion criteria (2 listed)
- Critical patients treated in intensive care unit using mechanical ventilation from day 0.
- Patients are clinically predicted to be treated for more than 5 days (qSOFA and clinical assessment)
Key exclusion criteria (4 listed)
- History of suffering from neuromuscular disease and or diaphragmatic malformations
- Used non-invasive ventilation before starting to use mechanical ventilation
- History of tracheostomy
- Patients admitted to ICU within 12 months before this study
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 |
|---|---|---|
| Ratio of Neutrophil to LymphocyteEach patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms. | Diagnostic test | Normal Diaphragm, Thinning Diaphragm |
| Level of Prealbumin SerumEach patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms. | Diagnostic test | Normal Diaphragm, Thinning Diaphragm |
Primary outcome
Level of Prealbumin Serum
Time frame: 5 days
Ratio of Neutrophil to Lymphocyte
Time frame: 5 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 2 Jan 2020.
- Results publication: PubMed 29851847Li C, Li X, Han H, Cui H, Wang G, Wang Z. Diaphragmatic ultrasonography for predicting ventilator weaning: A meta-analysis. Medicine (Baltimore). 2018 Jun;97(22):e10968. doi: 10.1097/MD.0000000000010968.
- Results publication: PubMed 27407022Flevari A, Lignos M, Konstantonis D, Armaganidis A. Diaphragmatic ultrasonography as an adjunct predictor tool of weaning success in patients with difficult and prolonged weaning. Minerva Anestesiol. 2016 Nov;82(11):1149-1157. Epub 2016 Jul 12.
- Results publication: PubMed 15127195Conti G, Montini L, Pennisi MA, Cavaliere F, Arcangeli A, Bocci MG, Proietti R, Antonelli M. A prospective, blinded evaluation of indexes proposed to predict weaning from mechanical ventilation. Intensive Care Med. 2004 May;30(5):830-6. doi: 10.1007/s00134-004-2230-8. Epub 2004 Mar 20.
- Results publication: PubMed 21373820Sellares J, Ferrer M, Cano E, Loureiro H, Valencia M, Torres A. Predictors of prolonged weaning and survival during ventilator weaning in a respiratory ICU. Intensive Care Med. 2011 May;37(5):775-84. doi: 10.1007/s00134-011-2179-3. Epub 2011 Mar 4.
- Results publication: PubMed 18241784Khan J, Harrison TB, Rich MM. Mechanisms of neuromuscular dysfunction in critical illness. Crit Care Clin. 2008 Jan;24(1):165-77, x. doi: 10.1016/j.ccc.2007.10.004.
- Individual participant dataSharing planned: Undecided
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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.
Rudyanto Sedono principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 4 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 2 Jan 2020. 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 Indonesia. 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. 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?
Level of Prealbumin Serum (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014439, which also lists 5 linked publications.
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 2 Jan 2020.