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Resuscitation Fluid Choice and Clinical Outcomes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02641119
Enrollment
65800
Registered
2015-12-29
Start date
2014-08-31
Completion date
2018-08-31
Last updated
2018-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Hyperchloremic Metabolic Acidosis, Large Volume Resuscitation

Keywords

Albumin, Resuscitation

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.

Interventions

None listed

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MortalityPrior to hospital discharge. Expected length of inpatient stay is 30 days.Number of patients who die prior to hospital discharge

Secondary

MeasureTime frameDescription
Development of Acute Kidney Injury (AKI)Within 72 hours following large volume resuscitationNumber of patients who develop AKI within 72 hours following large volume resuscitation
Development of Hyperchloremic metabolic acidosisWithin 24 hours following large volume resuscitationNumber of patients who develop Hyperchloremic metabolic acidosis within 24 hours following large volume resuscitation
Mortality1 year from ICU admissionNumber of patients who die within 1 year from ICU admission

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026