Resuscitation Fluid Choice and Clinical Outcomes

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Large Volume Resuscitation; Hyperchloremic Metabolic Acidosis

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.

• Study Type: Observational
• Enrollment (Actual): 65800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to any of eight ICUs at the University of Pittsburgh Medical Center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Albumin; Patients receiving any amount of 5% albumin during large volume resuscitation (defined as ≥ 60ml/kg in a single 24 hour period), as prescribed by treating clinician.
Saline-only; Patients receiving only saline during large volume resuscitation (defined as ≥ 60ml/kg in a single 24 hour period), as prescribed by treating clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of patients who die prior to hospital discharge	Prior to hospital discharge. Expected length of inpatient stay is 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of Acute Kidney Injury (AKI)	Number of patients who develop AKI within 72 hours following large volume resuscitation	Within 72 hours following large volume resuscitation
Development of Hyperchloremic metabolic acidosis	Number of patients who develop Hyperchloremic metabolic acidosis within 24 hours following large volume resuscitation	Within 24 hours following large volume resuscitation
Mortality	Number of patients who die within 1 year from ICU admission	1 year from ICU admission

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Publications and helpful links

General Publications

• Gomez H, Priyanka P, Bataineh A, Keener CM, Clermont G, Kellum JA. Effects of 5% Albumin Plus Saline Versus Saline Alone on Outcomes From Large-Volume Resuscitation in Critically Ill Patients. Crit Care Med. 2021 Jan 1;49(1):79-90. doi: 10.1097/CCM.0000000000004706.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Resuscitation; Albumin
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acid-Base Imbalance; Acute Kidney Injury; Acidosis
• Other Study ID Numbers: PRO13120333