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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2600125428 |
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最近更新日期: Date of Last Refreshed on: |
2026-05-27 08:45:31 |
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注册时间: Date of Registration: |
2026-05-27 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
胰腺炎住院期间痛风发作的风险因素:一项回顾性单中心研究 |
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Public title: |
Risk Factors for In-Hospital Gout Flares in Pancreatitis:A Retrospective Single-Center Study |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
急性胰腺炎患者住院期间痛风发作的危险因素分析 |
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Scientific title: |
Risk Factors for In-Hospital Gout Flares in Pancreatitis |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
周颖 |
研究负责人: |
周颖 |
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Applicant: |
Ying Zhou |
Study leader: |
Ying,Zhou |
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申请注册联系人电话: Applicant telephone: |
+86 574 87018587 |
研究负责人电话:
Study leader's |
+86 574 8701 8587 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
drzhouying07@126.com |
研究负责人电子邮件: Study leader's E-mail: |
drzhouying07@126.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
浙江省宁波市鄞州区兴宁路57号 |
研究负责人通讯地址: |
浙江省宁波市鄞州区兴宁路57号 |
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Applicant address: |
No. 57 Xingning Road, Yinzhou District, Ningbo, Zhejiang Province, China |
Study leader's address: |
No. 57 Xingning Road, Yinzhou District, Ningbo, Zhejiang Province, China |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
宁波市医疗中心李惠利医院 |
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Applicant's institution: |
Ningbo Medical Center Li Huili Hospital |
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研究负责人所在单位: |
宁波市医疗中心李惠利医院 |
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Affiliation of the Leader: |
Ningbo Medical Center Li Huili Hospital |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
李惠利医院伦审2026 研第166号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
宁波市医疗中心李惠利医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Ningbo Medical Center Li Huili Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-04-24 00:00:00 | ||
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伦理委员会联系人: |
章培 |
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Contact Name of the ethic committee: |
Zhang Pei |
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伦理委员会联系地址: |
浙江省宁波市鄞州区兴宁路57号 |
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Contact Address of the ethic committee: |
No. 57 Xingning Road, Yinzhou District, Ningbo, Zhejiang Province, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 574 87018834 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
542805676@qq.com |
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研究实施负责(组长)单位: |
宁波市医疗中心李惠利医院 |
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Primary sponsor: |
Ningbo Medical Centre Lihuili Hospital |
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研究实施负责(组长)单位地址: |
浙江省宁波市鄞州区兴宁路57号 |
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Primary sponsor's address: |
No. 57 Xingning Road, Yinzhou District, Ningbo, Zhejiang Province, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自选课题(自筹) |
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Source(s) of funding: |
No funding was received for this study. |
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研究疾病: |
急性胰腺炎 |
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Target disease: |
Acute pancreatitis |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
1.主要目的:急性胰腺炎患者住院期间出现痛风发作的危险因素。 2.次要目的:痛风发作对急性胰腺炎住院日、住院费用的影响。 |
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Objectives of Study: |
Primary objective: To explore potential risk factors for gout flares during hospitalization in patients with acute pancreatitis. Secondary objective: To assess the effect of gout flares on length of hospital stay and hospital costs. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
急性胰腺炎,伴痛风;分组:因急性胰腺炎住院、住院期间出现痛风发作者的为痛风发作组,既往有痛风病史但本次住院期间无发作者的为对照组。 |
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Inclusion criteria |
Acute pancreatitis with gout; Grouping: Patients hospitalized for acute pancreatitis who developed a gout flare during hospitalization were classified into the gout flare group, while those with a history of gout but no flare during this hospitalization were classified into the control group. |
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排除标准: |
1.入院时已经存在痛风发作; |
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Exclusion criteria: |
1.At admission, the patient already had a gout flare. |
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研究实施时间: Study execute time: |
从 From 2026-05-01 00:00:00至 To 2027-05-01 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-06-05 00:00:00 至 To 2026-06-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
不公开/Private |
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盲法: |
无 |
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Blinding: |
None |
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是否共享原始数据: IPD sharing |
是Yes |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
论文发表后半年内,通过备案系统网址共享数据https://www.medicalresearch.org.cn/。 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Within six months of publication, share data via the filing system website https://www.medicalresearch.org.cn/. |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
一、病例资料收集 本研究采用回顾性研究设计,通过医院电子病历系统及既往健康档案收集相关临床资料。 1. 一般临床资料 包括性别、年龄、身高、体重、体质量指数(BMI)、吸烟史及饮酒史。 2. 基础疾病及既往病史 包括高血压、冠心病、糖尿病、高脂血症、慢性肾功能不全、既往痛风病史,以及入院前12个月内最近一次血尿酸水平。 3. 急性胰腺炎相关临床特征 包括是否为首次急性胰腺炎发作、疾病严重程度分级、病因分型、是否合并器官衰竭(包括肾功能衰竭及呼吸功能衰竭)。 4. 住院期间临床管理指标 包括住院天数、住院费用、入院后24小时内液体复苏量、利尿剂使用情况、抗生素使用情况、肠内及/或肠外营养支持,以及是否接受连续肾脏替代治疗(CRRT)或血浆置换等特殊治疗。 5. 痛风相关治疗情况 包括降尿酸药物使用、预防复发药物使用、糖皮质激素、非甾体抗炎药(NSAIDs)及秋水仙碱使用情况。 6. 实验室检查指标 包括血尿酸(UA)、尿素氮(BUN)、血肌酐(Cr)、甘油三酯(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、空腹血糖(FBG)及C反应蛋白(CRP)。 二、数据采集与管理 本研究所有数据均来源于医院电子病历系统及既往健康档案,由研究者使用标准化数据采集表进行信息提取与整理。数据录入采用Microsoft Excel进行初步整理,统计分析使用SPSS软件(版本18.0)完成。本研究未使用电子数据采集系统(EDC)。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Methods – Data Collection 1. Clinical data collection This retrospective study collected clinical data from the hospital electronic medical record system and patients' previous health records. (1) Baseline characteristics Baseline variables included sex, age, height, weight, body mass index (BMI), smoking history, and alcohol consumption history. (2) Medical history and comorbidities Comorbidities included hypertension, coronary artery disease, diabetes mellitus, hyperlipidemia, and chronic renal insufficiency. Gout-related history included previous diagnosis of gout and the most recent serum uric acid level within 12 months prior to admission. (3) Clinical characteristics of acute pancreatitis Variables related to acute pancreatitis included first episode of acute pancreatitis, disease severity classification, etiology, and presence of organ failure, including renal failure and respiratory failure. (4) In-hospital management and clinical outcomes In-hospital variables included length of hospital stay, total hospitalization cost, fluid resuscitation volume within the first 24 hours of admission, use of diuretics, antibiotic therapy, enteral and/or parenteral nutritional support, and advanced treatments such as continuous renal replacement therapy (CRRT) or plasma exchange. (5) Gout-related treatments Gout-related medications included urate-lowering therapy, prophylactic anti-gout medications, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and colchicine. (6) Laboratory measurements Laboratory parameters included serum uric acid (UA), blood urea nitrogen (BUN), serum creatinine (Cr), triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), fasting blood glucose (FBG), and C-reactive protein (CRP). 2. Data management and statistical software All data were extracted and recorded using a standardized data collection form. Initial data entry and cleaning were performed using Microsoft Excel. Statistical analyses were conducted using SPSS (version 18.0). No electronic data capture (EDC) system was used in this study. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
无/No |