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临床试验/NCT04874779
NCT04874779已完成不适用

Risk of Acute Kidney Injury Among Patients Infected With COVID-19: A Retrospective Single Center Study

Zagazig University1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
The development of acute kidney injury or not following COVID-19

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

The development of acute kidney injury or not following COVID-19

时间窗: 2 months after enrollement

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed E Ghoniem

Clinical Professor - Associate Professor of Internal Medicine- Faculty of Medicine

Zagazig University

研究点 (1)

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