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Albumin vs Lactated Ringer's Solution in Heart Surgery

N/A
Recruiting
Led By Hossam Tantway, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients greater than 18 years of age undergoing CABG and AVR procedures
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights

Study Summary

This trial will compare two types of fluid solutions given to patients during heart surgery, to see which one is better at preventing kidney injury.

Who is the study for?
Adults over 18 years old scheduled for coronary artery bypass graft (CABG) or aortic valve replacement (AVR) surgeries can join this trial. It's not for those with end-stage kidney disease, very weak heart function, non-English speakers, chronic kidney issues, urgent surgery needs, recent severe kidney injury, or Jehovah's Witnesses due to potential blood transfusion conflicts.Check my eligibility
What is being tested?
The study is testing whether Albumin Solution or Lactated Ringer's Solution is better during CABG and AVR surgeries. The main focus is on the risk of acute kidney injury after surgery. Patients are randomly assigned to one of the two solutions in a double-blind setup where neither they nor the doctors know which one they're getting.See study design
What are the potential side effects?
Possible side effects from Albumin include allergic reactions and fluid overload. Lactated Ringer’s might cause electrolyte imbalances or reactions at the infusion site. Both solutions aim to manage fluid levels during surgery but may affect kidneys differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and will have heart surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Kidney Injury
Secondary outcome measures
Extubation time
Hospital readmission
Length of stay in the ICU
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lactated Ringer's SolutionExperimental Treatment1 Intervention
Participants will receive lactated Ringer's for fluid resuscitation post-surgery
Group II: Albumin SolutionExperimental Treatment1 Intervention
Participants will receive Albumin solution for fluid resuscitation post-surgery.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,737,921 Total Patients Enrolled
Hossam Tantway, MDPrincipal InvestigatorYale University

Media Library

Albumin Solution (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04652375 — N/A
Coronary Artery Bypass Surgery Research Study Groups: Albumin Solution, Lactated Ringer's Solution
Coronary Artery Bypass Surgery Clinical Trial 2023: Albumin Solution Highlights & Side Effects. Trial Name: NCT04652375 — N/A
Albumin Solution (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04652375 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this experiment?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical trial, first posted to the website in July 2021, is actively enrolling 400 participants at a single centre."

Answered by AI

Is the enrollment for this study still active?

"Affirmative. Clinicaltrials.gov details that this clinical experiment, which was initially released on July 1st 2021, is now enrolling participants. Around 400 patients are required from one single medical centre."

Answered by AI
~22 spots leftby Jul 2024