Skip to main content
Clinical Trials/NCT02641119
NCT02641119
Completed
Not Applicable

Association of Resuscitation Fluid Choice and Clinical Outcomes in Critically Ill Patients

University of Pittsburgh0 sites65,800 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Large Volume Resuscitation
Sponsor
University of Pittsburgh
Enrollment
65800
Primary Endpoint
Mortality
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This observational study evaluates the potential benefits, costs and clinical outcomes of albumin over saline and other non-saline fluids in patients receiving large volume resuscitation.

Detailed Description

Currently, recommended resuscitation paradigms involve a "crystalloid-first" approach. This approach reserves more potent and potentially more toxic colloids for patients that have already been exposed to large amounts of crystalloid and may have also experienced a delay in correcting their shock. This observational retrospective cohort study aims to identify predictors for large volume resuscitation (LVR) and model the potential benefits, costs and clinical outcomes of albumin over saline and other non-saline fluids in patients receiving large volume resuscitation. Further analyses will assess the risk of acute kidney injury (AKI) and hyperchloremic metabolic acidosis (HCA) associated with resuscitation fluid choice and examine long term outcomes such as development of end stage renal disease and post-discharge mortality up to 1 year following hospital discharge in patients treated with various fluid types This study will utilize data in a large, heterogeneous cohort (n=\~65,800) of critically ill patients admitted to the ICU over a 12 year period at the University of Pittsburgh Medical Center. The study population will consist of patients who receive large volume resuscitation (defined as \> 60ml/kg in a single 24 hour period) separated into analysis groups based on fluids administered during the defined 24 hour large volume resuscitation window. Patients presenting with AKI or HCA prior to large volume resuscitation will be excluded. AKI and "Severe" AKI will be diagnosed based on KDIGO criteria within 72 hours following LVR. Metabolic acidosis will be based on arterial blood gas measurements with a base deficit \> 2 mEq/l, with patients having chloride as the ion contributing to the majority of the acidosis being diagnosed with Hyperchloremic metabolic acidosis. Mortality at 30, 90, and 365-days from ICU admission will be ascertained using the social security death master file. Propensity score models will be used to determine the adjusted relationship between these clinical outcomes and type of fluid resuscitation employed.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
August 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Kellum

Director, Center for Critical Care Nephrology; Professor, Critical Care Medicine

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Critically ill patient admitted to ICU

Exclusion Criteria

  • History of chronic dialysis and/or renal transplant
  • Baseline serum creatinine \>= 4 mg/dl
  • Develop AKI or MA prior to LVR
  • Received OR fluids during LVR

Outcomes

Primary Outcomes

Mortality

Time Frame: Prior to hospital discharge. Expected length of inpatient stay is 30 days.

Number of patients who die prior to hospital discharge

Secondary Outcomes

  • Mortality(1 year from ICU admission)
  • Development of Acute Kidney Injury (AKI)(Within 72 hours following large volume resuscitation)
  • Development of Hyperchloremic metabolic acidosis(Within 24 hours following large volume resuscitation)

Similar Trials