Resuscitation Fluid Choice and Clinical Outcomes

NCT ID: NCT02641119

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-08-31

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.

Conditions

Large Volume Resuscitation; Acute Kidney Injury; Hyperchloremic Metabolic Acidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

John Kellum

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 33165027 (View on PubMed)

Other Identifiers

PRO13120333

Identifier Type: -

Identifier Source: org_study_id