Large Volume ResuscitationNCT02641119
Resuscitation Fluid Choice and Clinical Outcomes
An observational study of Large Volume Resuscitation and Acute Kidney Injury, run by University of Pittsburgh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Volume Resuscitation, Acute Kidney Injury, Hyperchloremic Metabolic Acidosis
- How many people
- 65,800 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to any of eight ICUs at the University of Pittsburgh Medical Center.
Who may be able to join
- Critically ill patient admitted to ICU
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Keywords
- Albumin, Resuscitation
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of patients who die prior to hospital discharge
Measured: Prior to hospital discharge. Expected length of inpatient stay is 30 days.
Secondary outcomes (3)
Development of Acute Kidney Injury (AKI)
Number of patients who develop AKI within 72 hours following large volume resuscitation
Measured: 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
Measured: Within 24 hours following large volume resuscitation
Mortality
Number of patients who die within 1 year from ICU admission
Measured: 1 year from ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startAug 2014
- Primary completionJan 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large Volume ResuscitationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kellum, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641119
- Sponsor's protocol ID
- PRO13120333
- Status last verified
- Nov 2018
- First submitted
- 29 Sep 2015
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33165027
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Resuscitation Fluid Choice and Clinical Outcomes in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02641119
- Acronym / sponsor ID
- PRO13120333
- Keywords
- Albumin, Resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65,800 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to any of eight ICUs at the University of Pittsburgh Medical Center.
Key inclusion criteria (1 listed)
- Critically ill patient admitted to ICU
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Prior to hospital discharge. Expected length of inpatient stay is 30 days.
Number of patients who die prior to hospital discharge
3 secondary outcomes
Development of Acute Kidney Injury (AKI)
Time frame: Within 72 hours following large volume resuscitation
Development of Hyperchloremic metabolic acidosis
Time frame: Within 24 hours following large volume resuscitation
Mortality
Time frame: 1 year from ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Derived from this study: PubMed 33165027Gomez 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Large Volume Resuscitation and Acute Kidney Injury, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Prior to hospital discharge. Expected length of inpatient stay is 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02641119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.