Lactated Ringers for Low Blood Pressure

Overseen By Antoinette Burger, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Missouri-Columbia

Disqualifiers: Emergency surgeries, Amputations, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether administering Lactated Ringers, a type of intravenous fluid, before surgery can prevent low blood pressure in patients undergoing a cystoscopy, a procedure to examine the bladder. The trial includes two groups: one receives the fluid before surgery, and the other does not. The researchers aim to determine if the fluid helps maintain stable blood pressure during the procedure. The trial seeks participants planning to have an elective cystoscopy who have no history of severe heart issues or allergies to the fluids used. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Lactated Ringers?

Research has shown that Lactated Ringer's solution is generally safe for people. It often treats low blood volume and low blood pressure by replacing lost fluids and minerals.

Most people tolerate it well, but some might experience side effects, such as allergic reactions like swelling under the skin, chest pain, changes in heart rate, or lower blood pressure.

These reactions are uncommon, but they can occur. Prospective trial participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Lactated Ringers for low blood pressure because it offers a fast-acting solution to stabilize patients before surgery. Unlike many traditional treatments that might focus on medications to constrict blood vessels or increase heart rate, Lactated Ringers provides a fluid bolus directly, which can quickly expand blood volume and improve cardiac output. This approach is particularly beneficial because it uses a simple isotonic solution, which is well-tolerated and can be quickly administered, potentially reducing the risk of complications during surgery.

What evidence suggests that Lactated Ringers might be an effective treatment for low blood pressure?

Research has shown that using Lactated Ringer's solution for fluid replacement can improve survival rates compared to regular saline. Studies have found that administering Ringer's Lactate before surgery helps maintain stable blood pressure. This trial will compare two approaches: one group will receive a preoperative fluid bolus of Lactated Ringer's, expected to prevent low blood pressure during cystoscopy procedures, while another group will not receive a fluid bolus. The treatment has already proven effective in managing fluid levels and blood pressure in other situations. ^{4 6 7 8 9}

Who Is on the Research Team?

Sagar Bansal, MD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for patients scheduled for elective cystoscopy who may experience low blood pressure after anesthesia induction. Specific eligibility details are not provided, but typically include adults meeting certain health standards.

Inclusion Criteria

Able to provide informed consent

I am scheduled for a bladder examination surgery.

Exclusion Criteria

Past history of amputations of any body part

I am not allergic to any medications used in the study or lactated ringers.

My heart's right ventricle has been severely weak in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Preoperative Assessment

Participants receive an ultrasound scan to determine cardiac output and may receive a fluid bolus of Lactated Ringers

Up to 24 hours

1 visit (in-person)

Surgery

Participants undergo cystoscopy with monitoring for postinduction hypotension

Up to 24 hours

Follow-up

Participants are monitored for safety and effectiveness after surgery

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Lactated Ringers

Trial Overview The study tests if giving a specific amount of Lactated Ringers solution, based on the patient's weight before surgery, can prevent a drop in blood pressure that sometimes happens after anesthesia is given.

How Is the Trial Designed?

Group I: Preoperative Fluid Bolus Experimental Treatment 1 Intervention

Patients will receive an ultrasound scan on their heart to determine cardiac output and will also receive a fluid bolus of Lactated Ringers before surgery.

Group II: No Treatment Active Control 1 Intervention

Patients will receive an ultrasound scan on their heart to determine cardiac output before surgery, but no fluid bolus will be given.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12047640/

Lactated Ringer's or Normal Saline for Initial Fluid ... Initial fluid resuscitation with lactated Ringer's solution, compared with 0.9% saline, might be associated with improved survival in patients ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02726620

Decision Support for Intraoperative Low Blood Pressure The study will look at both a change in patient outcome and a change in blood pressure management and will be performed at the Vanderbilt University Medical ...

3. journals.lww.com journals.lww.com/ccmjournal/fulltext/2025/05000/lactated_ringer_s_or_normal_saline_for_initial.10.aspx

Lactated Ringer's or Normal Saline for Initial Fluid... CONCLUSIONS: Initial fluid resuscitation with lactated Ringer's solution, compared with 0.9% saline, might be associated with improved survival in patients with ...

4. cureus.com cureus.com/articles/394708-a-comparative-study-of-preloading-with-ringers-lactate-and-intravenous-ephedrine-for-the-prevention-of-hypotension-due-to-propofol-during-induction-of-general-anesthesia

A Comparative Study of Preloading With Ringer's Lactate ... Both interventions were effective in maintaining hemodynamic stability. However, Ringer's lactate preloading showed more favorable SBP and DBP ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1566070222000108

Oral and intravenous hydration in the treatment of ... We conclude that oral salt replacement is indicated for treatment of neurogenic orthostatic hypotension because these patients have excessive renal sodium ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/lactated-ringer-s-intravenous-route/description/drg-20489612

Lactated ringer's (intravenous route) - Side effects & uses Lactated Ringer's injection is used to replace water and electrolyte loss in patients with low blood volume or low blood pressure.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/016682s117lbl.pdf

Lactated Ringer's Injection, USP - accessdata.fda.gov Hypersensitivity and infusion reactions: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, blood pressure decreased, respiratory ...

8. drugs.com drugs.com/cons/lactated-ringer-s.html

Lactated ringer's Advanced Patient Information Lactated Ringer's injection is used to replace water and electrolyte loss in patients with low blood volume or low blood pressure.

9. baxter.ca baxter.ca/sites/g/files/ebysai1431/files/2019-01/Lactated_Ringer_Injection_EN.pdf

Lactated Ringer's Injection, USP Safety and effectiveness of Lactated Ringer's ... pain, Chest discomfort, Decreased heart rate, Tachycardia, Blood pressure decreased,.