COVID-19 Positive Patients With Acute Kidney InjuryAKI-COVID-19NCT04979195
Acute Kidney Injury Among COVID-19 Positive Patients
An observational study of COVID-19 Positive Patients With Acute Kidney Injury, run by Hamid Al-Essa Organ Transplant Center at 2 sites in Kuwait.
Trial summary
In Kuwait, the total number of COVID-19 confirmed cases exceeds 5000 patients. Risk factors of possible risk factors of confirmed COVID-19 infection that developed major organ dysfunction are not yet identified among patients in Kuwait. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- COVID-19 Positive Patients With Acute Kidney Injury
- What is being tested?
- Patients with stable normal kidney function and Patients with unstable kidney function
- How many people
- 649 participants
- Where
- 2 sitesKuwait
- Study dates
- 1 Mar 2020to 31 Aug 2020
- How long will I take part?
- 30 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 21 to 90 years
- All sexes
- Adult, Older adult
Study population: 649 COVID-19 positive patients were identified. Sixty-three were isolated at home and 586 cases needed hospital admission during the period between the 1st week of March till the end of August 2020. Among the hospitalized cases, 258 needed ICU care while 328 were managed in the COVID general wards. We compared patients with stable renal function (group 1, n=319) vs. those who developed AKI (group 2, n=267). We collected the data from COVID-19 positive patients that were diagnosed in all government hospitals in Kuwait. Clinical features, details of management, and both patient and renal outcomes were recorded. We compiled patients' data from the electronic database of the isolation hospitals where COVID -19 cases were managed. Approval for the study was obtained from the ethical committee of the Kuwait Ministry of Health.
Who may be able to join
- All adult patients were included.
- Hospitalized with PCR confirmed COVID-19 infection.
- period between March to August 2020.
Who cannot join
- Pediatric patients Home isolated patients
Trial locations and contacts
2 sites in 1 country.
Kuwait2 sites
Osama Gheith
Kuwait City, AZ, 23424
Osama Gheith
Kuwait City, Rf, Kuwait
About this study
Official title: Acute Kidney Injury Among COVID-19 Positive Patients is Associated With Higher Mortality: a Single-center Experience
In Kuwait, the total number of COVID-19 confirmed cases exceeds 5000 patients. Risk factors of possible risk factors of confirmed COVID-19 infection that developed major organ dysfunction are not yet identified among patients in Kuwait.
we aimed to describe the clinical characteristics of hospitalized symptomatic COVID-19 positive patients, assess possible risk factors of confirmed COVID-19 infection who developed major organ dysfunction, determine risk factors for renal dysfunction and their outcome and assess the response of critically ill patients to different therapeutic modalities.
Read the detailed description
In this observational study, we will revise all medical records of hospitalized patients with laboratory-confirmed Covid-19, during the period between Feb till July 2020. A confirmed case of Covid-19 is defined as a positive result on high throughput sequencing or real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens.12 We will include only laboratory-confirmed cases in the analysis.
We will extract patients' data with special stress on socio-demographic data, associated medical co-morbidities as diabetes, hypertension, ischemic heart disease, chronic lung disease, recent exposure history, clinical symptoms or signs of the upper and lower respiratory system, and laboratory findings on admission. Radiologic assessments will be included like chest radiography or computed tomography (CT), and all laboratory testing will be performed according to the clinical care needs of the patient.
We will determine the presence of a radiologic abnormality on the basis of the documentation or description in medical charts of infected patients; if imaging scans were available, they were reviewed by attending physicians in respiratory medicine who will extract the data. If a major disagreement between two reviewers happens it will be resolved by consultation with a third reviewer. Laboratory assessments will include a complete blood count, blood chemical analysis, coagulation testing, assessment of liver and renal function, and measures of electrolytes, C-reactive protein, procalcitonin, lactate dehydrogenase, creatine kinase, ferritin, D dimer, and troponin. The degree of severity of Covid-19 (severe vs. non-severe) at the time of admission will be defined using the American Thoracic Society guidelines for community-acquired pneumonia.
Data will be entered into a computerized database SPSS program file and cross-checked. If the core data are missing, requests for clarification will be sent to the coordinators, who subsequently will contact the attending clinicians.
Treatment and Complications:
We will report patients who are receiving antibiotics, antiviral (different regimens), those who required oxygen therapy (invasive, non-invasive ventilation or extracorporeal membrane oxygenation, (ECMO)), and those patients who received systemic steroid therapy. Moreover, the duration of hospitalization will be reported. Also, patients who developed acute kidney injury will be recorded and if they were dialyzed, all dialysis parameters will be recorded including any associated complications. All mortality patients will be reported with special stress on the cause of death.
- Being tested
- Patients with stable normal kidney function, Patients with unstable kidney function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with stable normal kidney functionOther
Also called Covid-19 patients with stable kidney fucntion.
Covid-19 patients with stable kidney function will represent group 1.
Patients with unstable kidney functionOther
Also called Covid-19 patients with unstable kidney fucntion.
Covid-19 patients with unstable kidney function will represent group 2.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients with stable renal function. Receives: Other: Patients with stable normal kidney function; Other: Patients with unstable kidney function | |
| Group 2 | Patients who developed AKI. Receives: Other: Patients with stable normal kidney function; Other: Patients with unstable kidney function |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient survival
Patients who survived after 30 days.
Measured: 30 days
Kidney survival
Patients who have stable basal kidney function.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Mar 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Positive Patients With Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 649 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hamid Al-Essa Organ Transplant Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979195
- Sponsor's protocol ID
- 2020/1467
- Acronym
- AKI-COVID-19
- Status last verified
- Mar 2020
- First submitted
- 22 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury Among COVID-19 Positive Patients is Associated With Higher Mortality: a Single-center Experience
- ClinicalTrials.gov ID
- NCT04979195
- Acronym / sponsor ID
- AKI-COVID-19 / 2020/1467
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Hamid Al-Essa Organ Transplant CenterOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 Jul 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.
In Kuwait, the total number of COVID-19 confirmed cases exceeds 5000 patients. Risk factors of possible risk factors of confirmed COVID-19 infection that developed major organ dysfunction are not yet identified among patients in Kuwait.
we aimed to describe the clinical characteristics of hospitalized symptomatic COVID-19 positive patients, assess possible risk factors of confirmed COVID-19 infection who developed major organ dysfunction, determine risk factors for renal dysfunction and their outcome and assess the response of critically ill patients to different therapeutic modalities.
Detailed description
In this observational study, we will revise all medical records of hospitalized patients with laboratory-confirmed Covid-19, during the period between Feb till July 2020. A confirmed case of Covid-19 is defined as a positive result on high throughput sequencing or real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens.12 We will include only laboratory-confirmed cases in the analysis.
We will extract patients' data with special stress on socio-demographic data, associated medical co-morbidities as diabetes, hypertension, ischemic heart disease, chronic lung disease, recent exposure history, clinical symptoms or signs of the upper and lower respiratory system, and laboratory findings on admission. Radiologic assessments will be included like chest radiography or computed tomography (CT), and all laboratory testing will be performed according to the clinical care needs of the patient.
We will determine the presence of a radiologic abnormality on the basis of the documentation or description in medical charts of infected patients; if imaging scans were available, they were reviewed by attending physicians in respiratory medicine who will extract the data. If a major disagreement between two reviewers happens it will be resolved by consultation with a third reviewer. Laboratory assessments will include a complete blood count, blood chemical analysis, coagulation testing, assessment of liver and renal function, and measures of electrolytes, C-reactive protein, procalcitonin, lactate dehydrogenase, creatine kinase, ferritin, D dimer, and troponin. The degree of severity of Covid-19 (severe vs. non-severe) at the time of admission will be defined using the American Thoracic Society guidelines for community-acquired pneumonia.
Data will be entered into a computerized database SPSS program file and cross-checked. If the core data are missing, requests for clarification will be sent to the coordinators, who subsequently will contact the attending clinicians.
Treatment and Complications:
We will report patients who are receiving antibiotics, antiviral (different regimens), those who required oxygen therapy (invasive, non-invasive ventilation or extracorporeal membrane oxygenation, (ECMO)), and those patients who received systemic steroid therapy. Moreover, the duration of hospitalization will be reported. Also, patients who developed acute kidney injury will be recorded and if they were dialyzed, all dialysis parameters will be recorded including any associated complications. All mortality patients will be reported with special stress on the cause of death.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Patients with stable normal kidney function, Other: Patients with unstable kidney functionpatients with stable renal function. |
| Group 2 | – | Other: Patients with stable normal kidney function, Other: Patients with unstable kidney functionPatients who developed AKI. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 649 COVID-19 positive patients were identified. Sixty-three were isolated at home and 586 cases needed hospital admission during the period between the 1st week of March till the end of August 2020. Among the hospitalized cases, 258 needed ICU care while 328 were managed in the COVID general wards. We compared patients with stable renal function (group 1, n=319) vs. those who developed AKI (group 2, n=267). We collected the data from COVID-19 positive patients that were diagnosed in all government hospitals in Kuwait. Clinical features, details of management, and both patient and renal outcomes were recorded. We compiled patients' data from the electronic database of the isolation hospitals where COVID -19 cases were managed. Approval for the study was obtained from the ethical committee of the Kuwait Ministry of Health.
Key inclusion criteria (3 listed)
- All adult patients were included.
- Hospitalized with PCR confirmed COVID-19 infection.
- period between March to August 2020.
Key exclusion criteria (1 listed)
- Pediatric patients Home isolated patients
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 |
|---|---|---|
| Patients with stable normal kidney functionAlso: Covid-19 patients with stable kidney fucntion.Covid-19 patients with stable kidney function will represent group 1. | Other | Group 1, Group 2 |
| Patients with unstable kidney functionAlso: Covid-19 patients with unstable kidney fucntion.Covid-19 patients with unstable kidney function will represent group 2. | Other | Group 1, Group 2 |
Primary outcome
patient survival
Time frame: 30 days
Patients who survived after 30 days.
Kidney survival
Time frame: 30 days
Patients who have stable basal kidney function.
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 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Positive Patients With Acute Kidney Injury, run by Hamid Al-Essa Organ Transplant Center at 2 sites in Kuwait.
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 3 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 28 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 2 sites in Kuwait. 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?
patient survival (time frame: 30 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?
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 28 Jul 2021.