High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy

NCT03846258 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 18-010147
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to determine which dialysis solution, low bicarbonate fluid (22 mmol/L) or high bicarbonate fluid (32 mmol/L), is better in subjects with acute kidney injury (acute kidney failure) and metabolic acidosis that are admitted to the intensive care unit and require continuous renal replacement therapy (also known as continuous dialysis).

Conditions

Metabolic Acidosis; Acute Kidney Injury; Acute Kidney Failure

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Discharge status: death

  120 days

Secondary Outcomes (2)

• Time to achieve pH >7.3

  30 days

• Major Adverse Kidney events

  120 Days

Study Arms (2)

Low bicarbonate arm (22 mmol/L)

ACTIVE COMPARATOR

PHOXILLUM solutions are used as a replacement solution in Continuous Renal Replacement Therapy. The one to be used in this study has bicarbonate concentration of 22 mmol/L.

Drug: Low bicarbonate solution (22 mmol/L)

High Bicarbonate (32 mmol/L)

ACTIVE COMPARATOR

PrismaSATE is another replacement solution used in Continuous Renal Replacement Therapy. The one to be used in this study has bicarbonate concentration of 32 mmol/L.

Drug: High Bicarbonate solution (32 mmol/L)

Interventions

Low bicarbonate solution (22 mmol/L) DRUG

Participants randomized to this arm will be started on CRRT using Phoxillum as the replacement fluid.

Also known as: Phoxillum

Low bicarbonate arm (22 mmol/L)

High Bicarbonate solution (32 mmol/L) DRUG

Participants randomized to this arm will be started on CRRT using Prismasate as the replacement fluid.

Also known as: Prismasate

High Bicarbonate (32 mmol/L)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years of age)
• Ability to obtain informed consent, either from patient or legally authorized representative (LAR)
• Diagnosis of AKI according to KDIGO definition \[an increase in serum creatinine concentration of greater than or equal to 0.3 mg/dL within the first 48 hours of injury, a relative increase in serum creatinine of greater than or equal to 50% (1.5-fold from baseline) within the first 7 days of injury, or a reduction in urine output (\<0.5 mL/kg/h for more than 6 hours)\]
• CRRT initiated for the first time during current ICU admission.
• Bicarbonate ≤ 22 mEq/L
• Arterial pH between 7.05 and 7.25(if an ABG is not available, venous pH must be between 7.00 and 7.20)

You may not qualify if:

• Pregnancy (women of child-bearing potential must have a negative pregnancy test)
• Diagnosis of End-Stage renal disease and receiving Hemodialysis or peritoneal dialysis prior to ICU admission (this information will be easily obtained by the nephrology team)
• Arterial pH \<7.05 or \>7.25 (if an ABG is not available, Venous pH \<7.00 or \>7.20)
• Potassium level \>6.0 mmol/L
• Severe acute liver failure meeting all the following criteria):
• INR \>2
• AST/ALT more than 500 U/L and
• Bilirubin more than 12 mg/dL)
• Previous enrollment in this study

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Acidosis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kianoush B Kashani

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 19, 2019
• Study Start: May 1, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)