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Completed

NCT Number: NCT02641119

Resuscitation Fluid Choice and Clinical Outcomes

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Development of Acute Kidney Injury (AKI)

    Time frame: Within 72 hours following large volume resuscitation

    Number of patients who develop AKI within 72 hours following large volume resuscitation

  2. Development of Hyperchloremic metabolic acidosis

    Time frame: Within 24 hours following large volume resuscitation

    Number of patients who develop Hyperchloremic metabolic acidosis within 24 hours following large volume resuscitation

  3. Mortality

    Time frame: 1 year from ICU admission

    Number of patients who die within 1 year from ICU admission

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2015
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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