Indigotindisulfonate Sodium for Ureter Patency

Overseen By Michelle Boytim, P.hD.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Prove pharm

Disqualifiers: Chronic kidney failure, Hypersensitivity, Drug abuse, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

116 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well Bludigo™ (Indigotindisulfonate Sodium Injection) helps doctors determine if the ureters (tubes carrying urine from the kidneys to the bladder) are open during surgery. Participants will receive either a low or high dose of Bludigo™ to evaluate which dose is more effective and safer. Candidates for this trial include those scheduled for surgery who require ureter checks with cystoscopy (a procedure using a camera to examine the bladder). As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that any treatment that could affect the main evaluation is not allowed, so it's best to discuss your medications with the study team.

What is the safety track record for Bludigo™?

Research has shown that Bludigo™ (indigotindisulfonate sodium) is generally safe when used as a dye to check if the ureters (tubes from the kidneys to the bladder) are open during certain medical procedures. In previous studies, the most common side effect was a temporary blue color at the injection site and in urine, which usually disappeared within 48 hours.

However, rare reports have noted more serious allergic reactions, with symptoms like low blood pressure, difficulty breathing, and chest tightness. Anyone considering joining a trial should be aware of these.

Since the study is in phase 4, the FDA has already approved the treatment for use in other procedures, indicating a strong safety record. Participants should always discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for ensuring ureter patency, which typically involves mechanical stents or surgical procedures, Indigotindisulfonate Sodium offers a unique chemical approach. This treatment is exciting because it utilizes a dye known for its ability to highlight anatomical structures during surgeries, potentially offering a less invasive way to maintain ureter openness. Researchers are also interested in its dual dosing approach, where both low and high doses are being investigated to determine the optimal balance of efficacy and safety. This could pave the way for a more personalized treatment strategy, reducing the need for more invasive interventions.

What evidence suggests that Bludigo™ is effective for ureter patency?

This trial studies indigotindisulfonate sodium to help doctors determine if the ureters (the tubes carrying urine from the kidneys to the bladder) are open during surgery. Research has shown that indigotindisulfonate sodium helps doctors assess ureter openness, with past studies noting clear color differences 85.4% of the time, aiding in the evaluation of ureter health. Additionally, 82.1% of the ureters were rated as highly visible after using this treatment, proving more effective than saline (saltwater), the placebo comparator in this trial. The trial tests both low and high doses of indigotindisulfonate sodium, with previous research supporting its effectiveness in assessing ureter patency. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Adults aged 18-85 needing ureter patency assessment during surgery can join. Excluded are those with severe kidney failure, major systemic diseases, expected non-compliance, life expectancy under 6 months, pregnancy, breastfeeding, dye allergies or substance abuse within the last 6 months.

Inclusion Criteria

Subjects who signed a written IRB approved, informed consent form

I am scheduled for surgery that requires checking the health of my ureter afterwards.

Exclusion Criteria

Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g. major systemic diseases)

Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

I have advanced kidney failure or only one kidney.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive either a high dose (5.0 mL) or low dose (2.5 mL) of Bludigo™ on the day of surgery to assess ureteral patency

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events, ECG, and vital signs

4 weeks

1 visit (in-person), 1 call (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Indigotindisulfonate Sodium Injection, USP

Trial Overview The trial tests two doses of Bludigo™ (2.5 mL and 5.0 mL) against saline to check for ureter blockages during surgery. Participants serve as their own controls by getting saline before Bludigo™ and are randomly assigned to a dose level based on BMI.

How Is the Trial Designed?

Group I: Low Dose Experimental Treatment 2 Interventions

58 subjects randomly treated with 2.5 mL of drug

Group II: High Dose Experimental Treatment 2 Interventions

58 subjects randomly treated with 5 mL of drug

Group III: Saline Placebo Group 1 Intervention

116 subjects treated with 5 ml of saline then crossover to treatment arm

Who Is Running the Clinical Trial?

Prove pharm

Lead Sponsor

Trials

5

Recruited

330+

Published Research Related to This Trial

Indigo carmine, typically regarded as a safe dye for urinary tract examination, was associated with a severe anaphylactoid reaction and cardiac arrest in a patient after intravenous administration.

This case highlights the potential for serious allergic reactions to indigo carmine, emphasizing the need for caution and monitoring when using this agent in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life-threatening anaphylactoid reaction associated with indigo carmine intravenous injection. Gousse, AE., Safir, MH., Madjar, S., et al.[2019]

In a study of 303 women undergoing urogynecological surgery, the use of 10% dextrose in sterile water (D10) for cystoscopy was associated with a significantly higher rate of postoperative urinary tract infections (UTIs) compared to normal saline, with rates of 47.8% versus 25.9%, respectively.

Despite the increased UTI risk with D10, there were no significant differences in the rates of ureteral or lower urinary tract injuries between the D10 and normal saline groups, indicating that while D10 may help confirm ureteral patency, it poses a safety concern regarding infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates. Siff, LN., Unger, CA., Jelovsek, JE., et al.[2017]

Using 50% dextrose as a distension medium during cystoscopy allows for clear visualization of ureteric jets in all patients, unlike previous coloring agents that may not always provide consistent results.

The use of 50% dextrose does not interfere with the visualization of other bladder structures, making it a safe and effective alternative to indigotindisulfonate sodium for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 50% Dextrose as the Distension Medium During Cystoscopy for Visualization of Ureteric Jets. Narasimhulu, DM., Prabakar, C., Tang, N., et al.[2021]

Sodium fluorescein, administered intravenously in doses of 0.25 to 1.0 mL, provides excellent visualization of ureteral jets during cystoscopy, making it a viable alternative to the previously used indigotindisulfonate sodium.

While sodium fluorescein is effective, one patient experienced transient yellowing of the sclera and palms, indicating a potential side effect, but overall it is considered a safe option for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium fluorescein use during intraoperative cystoscopy. Doyle, PJ., Lipetskaia, L., Duecy, E., et al.[2022]

Indigo carmine, a blue dye commonly used in urologic and gynecologic procedures, is generally considered safe but can lead to serious adverse effects, as demonstrated in a case report.

In this case, a patient experienced hypotension, cardiac arrest, and cerebral ischemia following the administration of indigo carmine during a total laparoscopic hysterectomy, highlighting the need for caution even with routine interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac arrest from intravenous indigo carmine during laparoscopic surgery -A case report-. Lee, WJ., Jang, HS.[2021]

Citations

1. bludigo.com bludigo.com/efficacy/

Efficacy | Bludigo® (indigotindisulfonate sodium Injection, ... 85.4% of ureter patency assessments reported color contrasts in jet stream ranging from significant to striking 1. 89.6% of patients were defined as a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06054880?term=AREA%5BInterventionSearch%5D(INDIGOTINDISULFONATE%20SODIUM)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=6

Indigotindisulfonate Sodium Injection, USP as an Aid in the ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06054880/indigotindisulfonate-sodium-injection-usp-as-an-aid-in-the-determination-of-ureteral-patency

Indigotindisulfonate Sodium Injection, USP as an Aid in the ... This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo™ ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06085183

Indigotindisulfonate Sodium Injection, USP As an Aid in the ... This is an open label, randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Indigotindisulfonate ...

5. pfdweek24.eventscribe.net pfdweek24.eventscribe.net/ajaxcalls/PosterInfo.asp?efp=SEJFVkpKU1kxOTE3MQ&PosterID=674433&rnd=0.137688

Indigotindisulfonate Sodium vs Saline for Ureteral Patency ... 82.1% of ureters were scored ≥3 on the conspicuity scale following indigotindisulfonate sodium injection; both doses were significantly better than saline for ...

6. us.provepharm.com us.provepharm.com/sites/default/files/2023-06/FDS_Bludigo%20Indigotindisulfonate%20Sodium%200.8%25_PVP_ENG_V4%20%281%29.pdf

Bludigo, Indigotindisulfonate Sodium 0.8% Use as a visualization aid in the delineation of the integrity and patency of the ureters and bladder during urological and ... : This safety data ...

7. go.drugbank.com go.drugbank.com/drugs/DB11577

Indigotindisulfonic acid: Uses, Interactions, Mechanism of ... Indigotindisulfonic acid is a medication used to visualize ureteral orifices during cystoscopy and ureteral catheterization.

8. bludigo.com bludigo.com/safety/

Safety | Bludigo® (indigotindisulfonate sodium Injection, ... Inform the patient that Bludigo® may cause a blue discoloration of injection site and urine and that the discoloration should resolve within 48 hours.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/216264s000lbl.pdf

bludigo - accessdata.fda.gov Indigotindisulfonate sodium injection use during the first trimester of pregnancy is rare; thus, the data are insufficient to evaluate for a drug associated ...

10. synapse.patsnap.com synapse.patsnap.com/drug/c77a7e6307ae4aa6931fdb54e6eb661d

Indigotindisulfonate sodium - Drug Targets, Indications, ... Interrupt administration if reactions are observed. Hypersensitivity Reactions: Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, ...