- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04751838
Development and Validation of a Simple-to-use Nomogram for Predicting In-hospital Mortality in Acute Heart Failure Patients Undergoing Continuous Renal Replacement Therapy
Acute heart failure (AHF) is one of the most common causes of hospitalization and life-threatening medical condition around worldwide. The AHF patients admitted to the intensive care unit (ICU) usually be critically ill with multiorgan failure, in which the kidneys are most frequently involved. The goals of treatment of AHF in ICU were to improve hemodynamic stability and organ perfusion, alleviate symptoms, and limit cardiac and renal damage, which can be achieved by continuous renal replacement therapy (CRRT), a continuous extracorporeal blood purification. CRRT can mimic urine output to slowly and continuously remove patient's plasma water, providing accurate volume control and hemodynamic stability.
Acute Heart Failure Global Survey of Standard Treatment (ALARM-HF) study showed that hospital mortality of AHF patients was about 17.8% in the intensive care unit (ICU). But the patients undergoing CRRT, the mortality up to 45%-62.1%. For this reason, an early model or score to a screening of AHF patients undergoing CRRT who at high mortality risk is crucial, which can help clinicians to rapidly intervene and ameliorate disease outcomes. The most popular tools, especially that can predict mortality for critically ill patients, are the Acute Physiology Assessment and Chronic Health Evaluation II (APACHE II) scoring systems, and Simplified Acute Physiologic Score II (SAPS II). But variables in these scoring systems are complex, which was not convenient to assess at any time. Modified Early Warning Score (MEWS) , much more concise than APACHE II and SAPS II, not only can be used for early warning of the onset of AHF in patients with the risk of heart failure but also has a positive correlation with mortality in these patients. However, up to our knowledge, there was no scores or model to predict the in-hospital mortality of AHF patient undergoing CRRT.
Based on the acute heart failure unit (AHFU) of Qilu Hospital and the medical information mart for intensive care III (MIMIC III) database, the investigators collected the data of AHF adults undergoing CRRT. The present study aimed to develop and validate a simple-to-use nomogram model comprised of independent prognostic variables for predicting in-hospital mortality in AHF adults undergoing CRRT by using multivariate logistic regression analysis. With this model, the investigators can guide the early screening of high-risk patients in in-hospital mortality.
Study Overview
Detailed Description
The eligible patients randomly into training cohort and validation cohort. The univariate logistics regression analyses were performed to determine the independent risk characteristics in the training cohort of the presence of in-hospital all-cause death. Odds Ratios (ORs) and 95% confidence intervals (CIs) of these variables were estimated to quantify the strength of these associations. All variables that showed a univariate relationship with in-hospital mortality or that were considered clinically relevant were candidates for stepwise multivariate analysis in the training cohort. A nomogram model, producing by using the rms package, was formulated based on the results of independent risk factors in multivariate logistic regression. Based on the nomogram model, the total scores and prediction of in-hospital mortality risk of each patient were added by each eligible variable and then were converted to predicted probabilities both in the training cohort and validation cohort.
To evaluated the model for the prediction value of in-hospital mortality, firstly, the investigators calculated the calibration of the model was measured by calibration with 1000 bootstrap samples to decrease the overfit bias. Model fitting was assessed using the Hosmer-Lemeshow test to evaluate the goodness of fit. Secondly, the Harrell concordance index (C index) and receiver operating characteristic curve (ROC curve) to evaluate the predictive performance and discrimination of the nomogram. The ROC curve analysis was used to calculate the optimal cutoff values that were determined by maximizing the Youden index. Third, the clinical effectiveness of the resulting model was evaluated by decision curve analysis (DCA), which was a method for evaluating alternative diagnostic or prognostic tools that had advantages over others[16]. The increase in the discriminative value of MEWS and the resulting model for mortality was assessed by the net reclassification index (NRI).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Luyao Gao
- Phone Number: 15165110975
- Email: 15165110975@163.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital Of Shandong University
-
Contact:
- Luyao Gao
- Phone Number: 86-15165110975
- Email: 15165110975@163.com
-
Principal Investigator:
- Luyao Gao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of acute heart failure
- undergoing CRRT
Exclusion Criteria:
- died before CRRT
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Survivor cohort; Non-survivor Cohort
All patients were categorized according to the state of departure from the hospital, named survivor or non-survivor.
|
no intervention
|
Training Cohort, Validation Cohort
the eligible patients randomly (7:3) into training cohort and validation cohort.
The training cohort were used to build nomogram model, while the validation cohort validated the model.
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
in-hospital mortality
Time Frame: During hospitalization, an average of 20 days
|
according to the state of departure from the hospital, if the patient died, named in-hospital mortality
|
During hospitalization, an average of 20 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:
- Schaubroeck HA, Gevaert S, Bagshaw SM, Kellum JA, Hoste EA. Acute cardiorenal syndrome in acute heart failure: focus on renal replacement therapy. Eur Heart J Acute Cardiovasc Care. 2020 Oct;9(7):802-811. doi: 10.1177/2048872620936371. Epub 2020 Jun 29.
- Macedo E, Mehta RL. Continuous Dialysis Therapies: Core Curriculum 2016. Am J Kidney Dis. 2016 Oct;68(4):645-657. doi: 10.1053/j.ajkd.2016.03.427. Epub 2016 May 28. No abstract available.
- Ronco C, Ricci Z. Renal replacement therapies: physiological review. Intensive Care Med. 2008 Dec;34(12):2139-46. doi: 10.1007/s00134-008-1258-6. Epub 2008 Sep 13.
- Karkar A, Ronco C. Prescription of CRRT: a pathway to optimize therapy. Ann Intensive Care. 2020 Mar 6;10(1):32. doi: 10.1186/s13613-020-0648-y.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYLL-202011-114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure Acute
-
Idorsia Pharmaceuticals Ltd.CompletedAcute Heart Failure | Acute Decompensation of Chronic Heart Failure | New Onset of Heart FailureUnited States, United Kingdom, Israel, Switzerland, Austria, Denmark, France, Germany, Greece, Poland
-
Idorsia Pharmaceuticals Ltd.CompletedAcute Heart Failure | Acute Decompensation of Chronic Heart Failure | New Onset of Heart FailureUnited States, Hungary, Australia, Czechia, Germany, Italy, Norway, United Kingdom
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
Shanghai Chest HospitalUnknownAcute Renal Failure | Acute Heart FailureChina
-
Magenta Medical Ltd.TerminatedCongestive Heart Failure | Heart Failure, Congestive | Acute Heart FailureCroatia, Belgium, Serbia
-
University Medical Center GroningenCompletedHeart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteNetherlands
-
Jordan Cardio Vascular Research GroupRecruitingHeart Failure | Chronic Heart Failure | Acute Heart FailureJordan
-
Azienda Ospedaliera Città della Salute e della...Caretek S.r.l. Turin, Italy; Santer Reply S.p.A. Milan, ItalyUnknownHeart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteItaly
-
University Hospital, Clermont-FerrandHospices Civils de Lyon; University Hospital, Grenoble; Hôpital de la Croix-Rousse and other collaboratorsRecruitingHeart Failure | Chronic Heart Failure | Acute Heart FailureFrance
-
Clinica Alemana de SantiagoNot yet recruitingDecompensated Heart Failure | Heart Failure Acute
Clinical Trials on no intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of PittsburghCompletedChronic Low Back PainUnited States