Development and Validation of a Simple-to-use Nomogram for Predicting In-hospital Mortality in Acute Heart Failure Patients Undergoing Continuous Renal Replacement Therapy

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04751838
Collaborator
(none)
226
1
5
45.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
226 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Development and Validation of a Simple-to-use Nomogram for Predicting In-hospital Mortality in Acute Heart Failure Patients Undergoing Continuous Renal Replacement Therapy
Actual Study Start Date :
Oct 30, 2020
Anticipated Primary Completion Date :
Feb 28, 2021
Anticipated Study Completion Date :
Mar 30, 2021

Arms and Interventions

Arm 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.

Other: no intervention
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.

Other: no intervention
no intervention

Outcome Measures

Primary Outcome Measures

  1. in-hospital mortality [During hospitalization, an average of 20 days]

    according to the state of departure from the hospital, if the patient died, named in-hospital mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical diagnosis of acute heart failure

  • undergoing CRRT

Exclusion Criteria:
  • died before CRRT

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu Hospital of Shandong University Jinan Shandong China 250012

Sponsors and Collaborators

  • Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT04751838
Other Study ID Numbers:
  • KYLL-202011-114
First Posted:
Feb 12, 2021
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 12, 2021