Sever Acute Respiratory Syndrome and Acute Kidney InjuryNCT04874779
Acute Kidney Injury Risk in COVID-19
An observational study of Sever Acute Respiratory Syndrome and Acute Kidney Injury and Acute Kidney Injury, run by Zagazig University at 1 site in Egypt.
Trial summary
Background. Within a year, COVID-19 has advanced from being an outbreak to a pandemic, spreading rapidly and globally with devastating impact. Currently, there is an ongoing debate among scientists about the pathophysiological relationship between COVID-19 and acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sever Acute Respiratory Syndrome and Acute Kidney Injury, Acute Kidney Injury
- What is being tested?
- non
- How many people
- 83 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2020to 1 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients' medical history, underlying diseases, medications administered at home and in hospital, laboratory data, non-enhanced chest and abdominal computer tomography (CT) scans, were retrieved from electronic medical records. According to the Ministry of Health and Population (MOHP), Egypt Management protocol for COVID-19 Patients, version 1.4, 30th May,2020, (10), all patients received standard of care treatment including: (a) oxygen supply to achieve SaO2 ≥ 90%; (b) Hydroxychloroquine (400 mg twice in first day then 200 mg twice for 6 days); (C) Vitamin C (1gm daily); (d) Zinc (50mg daily); (e) Acetylcysteine 200 mg t.d.s.; (f) lactoferrin one sachet twice daily; (g) Anticoagulation if D-dimer > 1000.
Who may be able to join
- According to the WHO guidelines, a confirmed diagnosis of COVID-19 was defined as a positive result of a quantitative real-time reverse-transcriptase-polymerase chain reaction (RT-PCR) detection in a nasopharyngeal swab.
Who cannot join
- patients younger than 18 years, patients diagnosed with chronic kidney disease before admission, patients on maintenance dialysis or awaiting renal transplantation and patients taking any nephrotoxic medications a week prior to admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Acute Kidney Injury Among Patients Infected With COVID-19: A Retrospective Single Center Study
Background. Within a year, COVID-19 has advanced from being an outbreak to a pandemic, spreading rapidly and globally with devastating impact. Currently, there is an ongoing debate among scientists about the pathophysiological relationship between COVID-19 and acute kidney injury (AKI). While a few studies have concluded that the mechanisms of AKI in COVID-19 patients are seemingly multifactorial and have not been fully explicated, others asserted that AKI remains rare among COVID-19-related diseases. Considering this knowledge-gap and its potential impact on the management of COVID-19-associated AKI, our study aims to explore the prevalence of AKI and to identify possible risk factors associated with AKI development among COVID-19 hospitalized patients. Materials and Methods. This retrospective cohort study included 83 patients with COVID-19 hospitalized at AL-AHRAR Hospital, Zagazig, Egypt, between June and August,2020. Exclusion criteria were: patients younger than 18 years of age; diagnosed with end stage kidney disease; placed on maintenance dialysis; booked for a kidney transplant or on nephrotoxic medications. All patients included in the study underwent complete blood count; liver and renal function tests; examination of hemostasis parameters; inflammatory markers; serum electrolytes; routine urinalysis; arterial blood gas and non-enhanced chest and abdominal computer tomography (CT) scans
Read the detailed description
2.1. Study design and participants. Retrospective observational single-center study, including (83) laboratory-confirmed COVID-19 patients (age ≥ 18 years), hospitalized and isolated in the medical departments of AL-AHRAR Hospital, Zagazig, Egypt, from June 23 to August 29, 2020. All patients were isolated in the medical departments. None of them were admitted to the ICU or underwent mechanical ventilation. According to the WHO guidelines, a confirmed diagnosis of COVID-19 was defined as a positive result of a quantitative real-time reverse-transcriptase-polymerase chain reaction (RT-PCR) detection in a nasopharyngeal swab. (9) We excluded the following from this study: patients younger than 18 years, patients diagnosed with chronic kidney disease before admission, patients on maintenance dialysis or awaiting renal transplantation and patients taking any nephrotoxic medications a week prior to admission.
2.2. Data collection. The patients' medical history, underlying diseases, medications administered at home and in hospital, laboratory data, non-enhanced chest and abdominal computer tomography (CT) scans, were retrieved from electronic medical records. According to the Ministry of Health and Population (MOHP), Egypt Management protocol for COVID-19 Patients, version 1.4, 30th May,2020, (10), all patients received standard of care treatment including: (a) oxygen supply to achieve SaO2 ≥ 90%; (b) Hydroxychloroquine (400 mg twice in first day then 200 mg twice for 6 days); (C) Vitamin C (1gm daily); (d) Zinc (50mg daily); (e) Acetylcysteine 200 mg t.d.s.; (f) lactoferrin one sachet twice daily; (g) Anticoagulation if D-dimer > 1000.
2.3. Molecular detection of SARS-CoV-2 (RT-PCR). SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR) testing was performed on nasopharyngeal swabs using Thermofisher SCIENTIFIC's TaqPathTM COVID 19 CE IVD RT PCR Kit, 1000 reactions (Cat. No. A48067). The QUIAGEN extraction kit was used to extract viral RNA. Using Quick Dx Applied Biosystems 7500 real-time PCR instruments, the purified nucleic acid was reverse transcribed into cDNA and amplified using the TaqPathTM COVID 19 RT PCR Kit in one stage. Probes annealed to three unique SARS-CoV-2 target sequences: ORF1ab, nucleocapsid (N), and spike (S) primers/probes for bacteriophage MS2. The result was deemed null because two of the three genes and the MS2 (positive control) were all positive. COVID-19 was diagnosed whenever a positive real-time RT-PCR result was identified.
2.4. Laboratory procedures. Laboratory data included complete blood count by automated blood counter, liver and renal function tests by colorimetric method, examination of hemostasis parameters, inflammatory markers, serum Na, Serum K, serum Ca, urine dipstick test and arterial blood gas analysis.
2.5. Definitions. Acute kidney injury (AKI) was identified according to the guidelines of Kidney Disease Improving Global Outcomes (KDIGO). It is defined as any of the following: (I) an S.cr increase ≥0.3 mg/dL (≥26.5 μmol/L) within 48 h; or (II) an S.cr increase to ≥1.5 times baseline within the previous 7 days; or (III) a urine volume ≤0.5 mL/kg/h for 6 h. AKI is staged for severity according to the criteria presented in Table (1). (11) Urine output criteria were not used consistently for the diagnosis of AKI due to a lack of daily urine measurement in the electronic chart.
The Sequential Organ Failure Assessment (SOFA) score was developed as a morbidity severity score to focus on organ dysfunction, which can reliably predict disease severity and outcome. It includes 6 variables, each representing an organ system presented in Table (2). (12) Statistical Analyses. The SPSS software, version 26, was used for statistical analysis. ANOVA and univariate logistic regression analysis [odds ratio (OR) and 95% confidence intervals (CI)] were performed (significance level: P < 0.05).
Ethics statement. In order to maintain and ascertain the rights of patients without jeopardizing their privacy and confidentiality, informed verbal consents, in lieu of written informed consents, were obtained directly from all patients or their relatives. The requirements to obtain written informed consents were not attainable due to the inherent hazardous and contagious nature of COVID-19 epidemic, the strict restrictions by the hospital management, and the urgency of collecting the data.
- Being tested
- non
- Keywords
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonOther
follow up investigations
| Study group | Role | What they receive |
|---|---|---|
| Acute kidney injury (AKI) group | Acute kidney injury (AKI) group met the guidelines of Kidney Disease, Improving Global Outcomes (KDIGO) Receives: Other: non | |
| NON-Acute kidney injury (non-AKI) group | NON-Acute kidney injury (non-AKI) group not met the guidelines of Kidney Disease Improving Global Outcomes (KDIGO) Receives: Other: non |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of acute kidney injury or not following COVID-19
Measured: 2 months after enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start8 Jun 2020
- Primary completion18 Nov 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sever Acute Respiratory Syndrome and 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
- Other
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- University of Hail
- Responsible party
- Principal investigator, Mohamed E Ghoniem, Zagazig University
- Investigators
- mohamed ghonim, Principal investigator, Associate professor of Internal Medicine , faculty of medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874779
- Sponsor's protocol ID
- COVID-1927
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Acute Kidney Injury Among Patients Infected With COVID-19: A Retrospective Single Center Study
- ClinicalTrials.gov ID
- NCT04874779
- Acronym / sponsor ID
- COVID-1927
- Keywords
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- University of Hail
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 6 May 2021 (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.
Background. Within a year, COVID-19 has advanced from being an outbreak to a pandemic, spreading rapidly and globally with devastating impact. Currently, there is an ongoing debate among scientists about the pathophysiological relationship between COVID-19 and acute kidney injury (AKI). While a few studies have concluded that the mechanisms of AKI in COVID-19 patients are seemingly multifactorial and have not been fully explicated, others asserted that AKI remains rare among COVID-19-related diseases. Considering this knowledge-gap and its potential impact on the management of COVID-19-associated AKI, our study aims to explore the prevalence of AKI and to identify possible risk factors associated with AKI development among COVID-19 hospitalized patients. Materials and Methods. This retrospective cohort study included 83 patients with COVID-19 hospitalized at AL-AHRAR Hospital, Zagazig, Egypt, between June and August,2020. Exclusion criteria were: patients younger than 18 years of age; diagnosed with end stage kidney disease; placed on maintenance dialysis; booked for a kidney transplant or on nephrotoxic medications. All patients included in the study underwent complete blood count; liver and renal function tests; examination of hemostasis parameters; inflammatory markers; serum electrolytes; routine urinalysis; arterial blood gas and non-enhanced chest and abdominal computer tomography (CT) scans
Detailed description
2.1. Study design and participants. Retrospective observational single-center study, including (83) laboratory-confirmed COVID-19 patients (age ≥ 18 years), hospitalized and isolated in the medical departments of AL-AHRAR Hospital, Zagazig, Egypt, from June 23 to August 29, 2020. All patients were isolated in the medical departments. None of them were admitted to the ICU or underwent mechanical ventilation. According to the WHO guidelines, a confirmed diagnosis of COVID-19 was defined as a positive result of a quantitative real-time reverse-transcriptase-polymerase chain reaction (RT-PCR) detection in a nasopharyngeal swab. (9) We excluded the following from this study: patients younger than 18 years, patients diagnosed with chronic kidney disease before admission, patients on maintenance dialysis or awaiting renal transplantation and patients taking any nephrotoxic medications a week prior to admission.
2.2. Data collection. The patients' medical history, underlying diseases, medications administered at home and in hospital, laboratory data, non-enhanced chest and abdominal computer tomography (CT) scans, were retrieved from electronic medical records. According to the Ministry of Health and Population (MOHP), Egypt Management protocol for COVID-19 Patients, version 1.4, 30th May,2020, (10), all patients received standard of care treatment including: (a) oxygen supply to achieve SaO2 ≥ 90%; (b) Hydroxychloroquine (400 mg twice in first day then 200 mg twice for 6 days); (C) Vitamin C (1gm daily); (d) Zinc (50mg daily); (e) Acetylcysteine 200 mg t.d.s.; (f) lactoferrin one sachet twice daily; (g) Anticoagulation if D-dimer > 1000.
2.3. Molecular detection of SARS-CoV-2 (RT-PCR). SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR) testing was performed on nasopharyngeal swabs using Thermofisher SCIENTIFIC's TaqPathTM COVID 19 CE IVD RT PCR Kit, 1000 reactions (Cat. No. A48067). The QUIAGEN extraction kit was used to extract viral RNA. Using Quick Dx Applied Biosystems 7500 real-time PCR instruments, the purified nucleic acid was reverse transcribed into cDNA and amplified using the TaqPathTM COVID 19 RT PCR Kit in one stage. Probes annealed to three unique SARS-CoV-2 target sequences: ORF1ab, nucleocapsid (N), and spike (S) primers/probes for bacteriophage MS2. The result was deemed null because two of the three genes and the MS2 (positive control) were all positive. COVID-19 was diagnosed whenever a positive real-time RT-PCR result was identified.
2.4. Laboratory procedures. Laboratory data included complete blood count by automated blood counter, liver and renal function tests by colorimetric method, examination of hemostasis parameters, inflammatory markers, serum Na, Serum K, serum Ca, urine dipstick test and arterial blood gas analysis.
2.5. Definitions. Acute kidney injury (AKI) was identified according to the guidelines of Kidney Disease Improving Global Outcomes (KDIGO). It is defined as any of the following: (I) an S.cr increase ≥0.3 mg/dL (≥26.5 μmol/L) within 48 h; or (II) an S.cr increase to ≥1.5 times baseline within the previous 7 days; or (III) a urine volume ≤0.5 mL/kg/h for 6 h. AKI is staged for severity according to the criteria presented in Table (1). (11) Urine output criteria were not used consistently for the diagnosis of AKI due to a lack of daily urine measurement in the electronic chart.
The Sequential Organ Failure Assessment (SOFA) score was developed as a morbidity severity score to focus on organ dysfunction, which can reliably predict disease severity and outcome. It includes 6 variables, each representing an organ system presented in Table (2). (12) Statistical Analyses. The SPSS software, version 26, was used for statistical analysis. ANOVA and univariate logistic regression analysis [odds ratio (OR) and 95% confidence intervals (CI)] were performed (significance level: P < 0.05).
Ethics statement. In order to maintain and ascertain the rights of patients without jeopardizing their privacy and confidentiality, informed verbal consents, in lieu of written informed consents, were obtained directly from all patients or their relatives. The requirements to obtain written informed consents were not attainable due to the inherent hazardous and contagious nature of COVID-19 epidemic, the strict restrictions by the hospital management, and the urgency of collecting the data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute kidney injury (AKI) group | – | Other: nonAcute kidney injury (AKI) group met the guidelines of Kidney Disease, Improving Global Outcomes (KDIGO) |
| NON-Acute kidney injury (non-AKI) group | – | Other: nonNON-Acute kidney injury (non-AKI) group not met the guidelines of Kidney Disease Improving Global Outcomes (KDIGO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients' medical history, underlying diseases, medications administered at home and in hospital, laboratory data, non-enhanced chest and abdominal computer tomography (CT) scans, were retrieved from electronic medical records. According to the Ministry of Health and Population (MOHP), Egypt Management protocol for COVID-19 Patients, version 1.4, 30th May,2020, (10), all patients received standard of care treatment including: (a) oxygen supply to achieve SaO2 ≥ 90%; (b) Hydroxychloroquine (400 mg twice in first day then 200 mg twice for 6 days); (C) Vitamin C (1gm daily); (d) Zinc (50mg daily); (e) Acetylcysteine 200 mg t.d.s.; (f) lactoferrin one sachet twice daily; (g) Anticoagulation if D-dimer > 1000.
Key inclusion criteria (1 listed)
- According to the WHO guidelines, a confirmed diagnosis of COVID-19 was defined as a positive result of a quantitative real-time reverse-transcriptase-polymerase chain reaction (RT-PCR) detection in a nasopharyngeal swab.
Key exclusion criteria (1 listed)
- patients younger than 18 years, patients diagnosed with chronic kidney disease before admission, patients on maintenance dialysis or awaiting renal transplantation and patients taking any nephrotoxic medications a week prior to admission
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 |
|---|---|---|
| nonfollow up investigations | Other | Acute kidney injury (AKI) group, NON-Acute kidney injury (non-AKI) group |
Primary outcome
The development of acute kidney injury or not following COVID-19
Time frame: 2 months after enrollement
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 23 Jul 2021.
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.
mohamed ghonim principal investigator
Associate professor of Internal Medicine , 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 Sever Acute Respiratory Syndrome and Acute Kidney Injury and Acute Kidney Injury, 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 1 inclusion and 1 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 23 Jul 2021. 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?
The development of acute kidney injury or not following COVID-19 (time frame: 2 months after enrollement). 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 23 Jul 2021.