RECOST: Recovery of Serum Creatinine at Discharge Impacts Mortality

• Sponsor: Guangdong Provincial People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03417791
• Collaborator: (none)
• Enrollment: 20,000
• Location: 1
• Anticipated Duration (Months): 143.9
• Patients Per Site Per Month: 139

Study Details

Study Description

Brief Summary

The aim of our study is to assess the mortality in the in-hospital patients who have elevated serum creatinine. A registry of patients with increased serum creatinine during hospital was conducted at the Guangdong General Hospital from January 1st, 2007 to December 30th, 2013. The primary clinical outcome is all-cause mortality, followed from the date of hospital discharge to Dec 30th 2018. Patients were divided into three groups, according to the serum creatinine recovery ratio (discharge/max serum creatinine). All-cause mortality, including the date of death, was identified from the electronic hospitalization data, phone follow-up, and confirmed by the household registration (HUKOU) system, a record of registration required by law in China. Baseline characteristics, including primary disease diagnosis, blood pressure, major treatment, drug use and et al, were collected. Demographic data were collected from the electronic hospitalization data and electronic hospital discharge records. All co-morbid conditions were identified using International Statistical Classification of Diseases, Tenth Revision (ICD-10), coding algorithms applied to electronic physician claims and electronic hospital discharge records.

Condition or Disease	Intervention/Treatment	Phase
Kidney; Functional Disturbance	Other: no intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Recovery of Serum Creatinine at Discharge Impacts Mortality, Long-term and Short-term
• Actual Study Start Date: Jan 1, 2007
• Anticipated Primary Completion Date: Dec 30, 2018
• Anticipated Study Completion Date: Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
kidney function recovery the registry and follow up of consecutive patients with increased serum creatinine during hospital in 2007	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. all-cause mortality [10 years]

   all-cause mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• In-hospital patients in Guangdong General Hospital in 2007

• Age>=18y

• Patients with increased serum creatinine during hospital

Exclusion Criteria:

• Death during hospital

• Diagnosed with End-stage renal disease

• given the renal replace therapy during hospital

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong General Hospital	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Guangdong Provincial People's Hospital

Investigators

• Study Director: Liming Yao, M.D., Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangdong Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT03417791
• Other Study ID Numbers: GDREC2017296H
• First Posted: Jan 31, 2018
• Last Update Posted: Jan 31, 2018
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guangdong Provincial People's Hospital: recovery; serum creatinine

Study Results

No Results Posted as of Jan 31, 2018