Acute Kidney InjuryNCT04154007
Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome
An observational study of Acute Kidney Injury and Acute Respiratory Distress Syndrome, run by Zagazig University at 1 site in Egypt.
Trial summary
Several studies suggested that ARDS may have important adverse effects on renal function, but few studies have specifically addressed the risk factors of AKI and its impact on the outcome in theses patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Acute Respiratory Distress Syndrome
- What is being tested?
- kidney function tests - urine output
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 30 Mar 2019
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: 81 ARDS patients admitted to the Respiratory, Surgical and Internal Medicine Intensive Care unit, Zagazig University Hospitals during the period from September 2017 to March 2019
Who may be able to join
- Adult Patients (≥18 years old)
- diagnosis of ARDS according to Berlin definition
Who cannot join
- Patients with preexisting chronic kidney disease
- AKI prior to the onset of ARDS
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Respiratory, Surgical, Internal medicine ICUs, Zagazig University Hospitals
Zagazig, Sharqia Province, 44111
About this study
Official title: Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome: Incidence, Risk Factors and Its Impact on the Outcome
Several studies suggested that ARDS may have important adverse effects on renal function, but few studies have specifically addressed the risk factors of AKI and its impact on the outcome in theses patients.
Read the detailed description
Acute respiratory distress syndrome is considered an acute diffuse lung injury in which an inciting inflammatory event is followed by hypoxemic respiratory failure. Despite advances in the management of ARDS, the mortality remains high. The LUNG SAFE study reported that hospital mortality was 34.9% in patients with mild ARDS, 40.3% in patients with moderate ARDS, and 46.1% in patients with severe ARDS. Understanding the prognostic factors in ARDS is essential for decreasing its mortality. Acute kidney injury (AKI) is a common and challenging medical condition in critically ill patients, in which there is a sudden renal impairment during hours to days and it is known to be associated with increased mortality .Other adverse outcomes associated with AKI includes chronic kidney disease (CKD) and high cardio-vascular complications. The incidence of AKI in hospitalized adults was reported to be 22% with a mortality rate of 24%. The severity of AKI ranges from stage 1 to stage 3 according to The KDIGO (Kidney Disease: Improving Global Outcomes) system, based on decreased urine output over time, or increases in serum creatinine, or both.
- Being tested
- kidney function tests - urine output
- Medical subject headings
- Acute Kidney Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney function tests - urine outputDiagnostic test
AKI was classified based on the worst of either creatinine or urine output criterion as follows:
Stage I 1.5-1.9 times baseline OR ≥0.3 mg/dl increase in the serum creatinine, OR urine output <0.5 ml/kg per hour for 6 to 12 hours.
Stage II 2.0-2.9 times baseline increase in the serum creatinine OR urine output <0.5 ml/kg per hour for ≥12 hours.
Stage III 3.0 times baseline increase in the serum creatinine OR increase in serum creatinine to ≥4.0 mg OR urine output of <0.3 ml/kg per hour for ≥24 hours, OR anuria for ≥12 hours OR the initiation of renal replacement therapy.
| Study group | Role | What they receive |
|---|---|---|
| Adult Patients who met the diagnosis of ARDS | ARDS patients were followed for the development of AKI during their ICU stay Receives: Diagnostic Test: kidney function tests - urine output |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of AKI
AKI was classified based on the worst of either creatinine or urine output criterion as follows:
Stage I 1.5-1.9 times baseline OR ≥0.3 mg/dl increase in the serum creatinine, OR urine output <0.5 ml/kg per hour for 6 to 12 hours.
Stage II 2.0-2.9 times baseline increase in the serum creatinine OR urine output <0.5 ml/kg per hour for ≥12 hours.
Stage III 3.0 times baseline increase in the serum creatinine OR increase in serum creatinine to ≥4.0 mg OR urine output of <0.3 ml/kg per hour for ≥24 hours, OR anuria for ≥12 hours OR the initiation of renal replacement therapy.
Measured: 30 days
Secondary outcomes (3)
ICU length of stay.
development of AKI affects the ICU stay
Measured: 30 days
hospital length of stay.
development of AKI may affect the length of stay in hospital
Measured: 90 days
Hospital mortality
the effect of development of AKI on the mortality of ARDS patients
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Sep 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sherif M. S. Mowafy, Zagazig University
- Investigators
- Eman Shebl, MD, Study director, Chest department, Faculty of Medicine, Zagazig UniversityLamiaa G Zake, MD, Principal investigator, Chest department, Faculty of Medicine, Zagazig UniversitySherif MS Mowafy, MD, Principal investigator, Anesthesia and Surgical Intensive Care department, Faculty of Medicine, Zagazig UniversityAyman R Abd El-Hameed, MD, Principal investigator, Nephrology Internal Medicine department, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154007
- Sponsor's protocol ID
- 5670/17-10-2019
- Status last verified
- Nov 2019
- First submitted
- 3 Nov 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Peter JV, John P, Graham PL, Moran JL, George IA, Bersten A. Corticosteroids in the prevention and treatment of acute respiratory distress syndrome (ARDS) in adults: meta-analysis. BMJ. 2008 May 3;336(7651):1006-9. doi: 10.1136/bmj.39537.939039.BE. Epub 2008 Apr 23.
PubMed 18434379Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Cartin-Ceba R, Haugen EN, Iscimen R, Trillo-Alvarez C, Juncos L, Gajic O. Evaluation of "Loss" and "End stage renal disease" after acute kidney injury defined by the Risk, Injury, Failure, Loss and ESRD classification in critically ill patients. Intensive Care Med. 2009 Dec;35(12):2087-95. doi: 10.1007/s00134-009-1635-9. Epub 2009 Sep 15.
PubMed 19756503Hoste EA, Schurgers M. Epidemiology of acute kidney injury: how big is the problem? Crit Care Med. 2008 Apr;36(4 Suppl):S146-51. doi: 10.1097/CCM.0b013e318168c590.
PubMed 18382186Coca SG, Cho KC, Hsu CY. Acute kidney injury in the elderly: predisposition to chronic kidney disease and vice versa. Nephron Clin Pract. 2011;119 Suppl 1(Suppl 1):c19-24. doi: 10.1159/000328023. Epub 2011 Aug 10.
PubMed 21832852Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL; Acute Kidney Injury Advisory Group of the American Society of Nephrology. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93. doi: 10.2215/CJN.00710113. Epub 2013 Jun 6.
PubMed 23744003Fischer MJ, Brimhall BB, Lezotte DC, Glazner JE, Parikh CR. Uncomplicated acute renal failure and hospital resource utilization: a retrospective multicenter analysis. Am J Kidney Dis. 2005 Dec;46(6):1049-57. doi: 10.1053/j.ajkd.2005.09.006.
PubMed 16310570Kidney Disease: Improving global outcomes (KDIGO) acute kidney injury working group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int Suppl (2012). 2012;2(1):1-138.
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Hoste EA, Clermont G, Kersten A, Venkataraman R, Angus DC, De Bacquer D, Kellum JA. RIFLE criteria for acute kidney injury are associated with hospital mortality in critically ill patients: a cohort analysis. Crit Care. 2006;10(3):R73. doi: 10.1186/cc4915. Epub 2006 May 12.
PubMed 16696865
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome: Incidence, Risk Factors and Its Impact on the Outcome
- ClinicalTrials.gov ID
- NCT04154007
- Acronym / sponsor ID
- 5670/17-10-2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 6 Nov 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.
Several studies suggested that ARDS may have important adverse effects on renal function, but few studies have specifically addressed the risk factors of AKI and its impact on the outcome in theses patients.
Detailed description
Acute respiratory distress syndrome is considered an acute diffuse lung injury in which an inciting inflammatory event is followed by hypoxemic respiratory failure. Despite advances in the management of ARDS, the mortality remains high. The LUNG SAFE study reported that hospital mortality was 34.9% in patients with mild ARDS, 40.3% in patients with moderate ARDS, and 46.1% in patients with severe ARDS. Understanding the prognostic factors in ARDS is essential for decreasing its mortality. Acute kidney injury (AKI) is a common and challenging medical condition in critically ill patients, in which there is a sudden renal impairment during hours to days and it is known to be associated with increased mortality .Other adverse outcomes associated with AKI includes chronic kidney disease (CKD) and high cardio-vascular complications. The incidence of AKI in hospitalized adults was reported to be 22% with a mortality rate of 24%. The severity of AKI ranges from stage 1 to stage 3 according to The KDIGO (Kidney Disease: Improving Global Outcomes) system, based on decreased urine output over time, or increases in serum creatinine, or both.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Patients who met the diagnosis of ARDS | – | Diagnostic Test: kidney function tests - urine outputARDS patients were followed for the development of AKI during their ICU stay |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 81 ARDS patients admitted to the Respiratory, Surgical and Internal Medicine Intensive Care unit, Zagazig University Hospitals during the period from September 2017 to March 2019
Key inclusion criteria (2 listed)
- Adult Patients (≥18 years old)
- diagnosis of ARDS according to Berlin definition
Key exclusion criteria (2 listed)
- Patients with preexisting chronic kidney disease
- AKI prior to the onset of ARDS
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 |
|---|---|---|
| kidney function tests - urine outputAKI was classified based on the worst of either creatinine or urine output criterion as follows: Stage I 1.5-1.9 times baseline OR ≥0.3 mg/dl increase in the serum creatinine, OR urine output <0.5 ml/kg per hour for 6 to 12 hours. Stage II 2.0-2.9 times baseline increase in the serum creatinine OR urine output <0.5 ml/kg per hour for ≥12 hours. Stage III 3.0 times baseline increase in the serum creatinine OR increase in serum creatinine to ≥4.0 mg OR urine output of <0.3 ml/kg per hour for ≥24 hours, OR anuria for ≥12 hours OR the initiation of renal replacement therapy. | Diagnostic test | Adult Patients who met the diagnosis of ARDS |
Primary outcome
development of AKI
Time frame: 30 days
AKI was classified based on the worst of either creatinine or urine output criterion as follows: Stage I 1.5-1.9 times baseline OR ≥0.3 mg/dl increase in the serum creatinine, OR urine output <0.5 ml/kg per hour for 6 to 12 hours. Stage II 2.0-2.9 times baseline increase in the serum creatinine OR urine output <0.5 ml/kg per hour for ≥12 hours. Stage III 3.0 times baseline increase in the serum creatinine OR increase in serum creatinine to ≥4.0 mg OR urine output of <0.3 ml/kg per hour for ≥24 hours, OR anuria for ≥12 hours OR the initiation of renal replacement therapy.
3 secondary outcomes
ICU length of stay.
Time frame: 30 days
hospital length of stay.
Time frame: 90 days
Hospital mortality
Time frame: 90 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 6 Nov 2019.
- Background: PubMed 18434379Peter JV, John P, Graham PL, Moran JL, George IA, Bersten A. Corticosteroids in the prevention and treatment of acute respiratory distress syndrome (ARDS) in adults: meta-analysis. BMJ. 2008 May 3;336(7651):1006-9. doi: 10.1136/bmj.39537.939039.BE. Epub 2008 Apr 23.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Background: PubMed 19756503Cartin-Ceba R, Haugen EN, Iscimen R, Trillo-Alvarez C, Juncos L, Gajic O. Evaluation of "Loss" and "End stage renal disease" after acute kidney injury defined by the Risk, Injury, Failure, Loss and ESRD classification in critically ill patients. Intensive Care Med. 2009 Dec;35(12):2087-95. doi: 10.1007/s00134-009-1635-9. Epub 2009 Sep 15.
- Background: PubMed 18382186Hoste EA, Schurgers M. Epidemiology of acute kidney injury: how big is the problem? Crit Care Med. 2008 Apr;36(4 Suppl):S146-51. doi: 10.1097/CCM.0b013e318168c590.
- Background: PubMed 21832852Coca SG, Cho KC, Hsu CY. Acute kidney injury in the elderly: predisposition to chronic kidney disease and vice versa. Nephron Clin Pract. 2011;119 Suppl 1(Suppl 1):c19-24. doi: 10.1159/000328023. Epub 2011 Aug 10.
- Background: PubMed 23744003Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL; Acute Kidney Injury Advisory Group of the American Society of Nephrology. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93. doi: 10.2215/CJN.00710113. Epub 2013 Jun 6.
- Background: PubMed 16310570Fischer MJ, Brimhall BB, Lezotte DC, Glazner JE, Parikh CR. Uncomplicated acute renal failure and hospital resource utilization: a retrospective multicenter analysis. Am J Kidney Dis. 2005 Dec;46(6):1049-57. doi: 10.1053/j.ajkd.2005.09.006.
- BackgroundKidney Disease: Improving global outcomes (KDIGO) acute kidney injury working group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int Suppl (2012). 2012;2(1):1-138.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 16696865Hoste EA, Clermont G, Kersten A, Venkataraman R, Angus DC, De Bacquer D, Kellum JA. RIFLE criteria for acute kidney injury are associated with hospital mortality in critically ill patients: a cohort analysis. Crit Care. 2006;10(3):R73. doi: 10.1186/cc4915. Epub 2006 May 12.
- Individual participant dataSharing planned: Yes. All collected IPD
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Eman Shebl, MD study director
Chest department, Faculty of Medicine, Zagazig University
Lamiaa G Zake, MD principal investigator
Chest department, Faculty of Medicine, Zagazig University
Sherif MS Mowafy, MD principal investigator
Anesthesia and Surgical Intensive Care department, Faculty of Medicine, Zagazig University
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 Acute Kidney Injury and Acute Respiratory Distress Syndrome, run by Zagazig 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 2 inclusion and 2 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 6 Nov 2019. 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. 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?
development of AKI (time frame: 30 days). 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 NCT04154007, which also lists 10 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 6 Nov 2019.