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Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03882658
Recruitment Status : Completed
First Posted : March 20, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Yan Zhou, MD, Peking University First Hospital

Study Description
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Brief Summary:
Acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. However, due to ethic issue and nonlinear realtionship between these factors and postoperative acute kidney injury, the exact threshold of these two risk factors were not be able to identified. The research tried to locate the exact threshold with implementation of penalized splines by generalized additive model.

Condition or disease
Acute Kidney Injury

Study Design
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Study Type : Observational
Actual Enrollment : 37610 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury: a Retrospective Cohort Analysis
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : January 20, 2019
Actual Study Completion Date : February 15, 2019

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. incidence and odds ratio of postoperative acute kidney injury [ Time Frame: 30 days postoperatively in hospital ]
    incidence and odds ratio of postoperative acute kidney injury


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult non-cardiac, non-obsteric, non- kidney elective surgery patients
Criteria

Inclusion Criteria:

adult non-cardiac, non-obsteric, non- kidney elective surgery patients

Exclusion Criteria:

patients aged <18 y emergency surgeries without arterial blood pressure cardiac surgeries obstetric surgeries kidney surgeries under local infiltration or MAC first SBP <100 mmHg

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882658


Locations
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China, Beijing
First hospital Peking University
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Yan Zhou, MD, PhD Peking University First Hospital
More Information
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Responsible Party: Yan Zhou, MD, Principal Investigator, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03882658    
Other Study ID Numbers: ALBHYTAKI
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Hypotension
Wounds and Injuries
Renal Insufficiency
 Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases