Arterial pH and Total Body Nitrogen Balances in APD

NCT00586131 | Completed Phase 4 DMC

• 1 other identifier: 11043
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the hypothesis that by slightly lowering the acidity of blood (or increasing the pH), dialysis patients utilize protein and amino acids more efficiently.

Conditions

End-stage Renal Disease

Keywords

end-stage renal disease; automated peritoneal dialysis; metabolic acidosis; nitrogen balances

Outcome Measures

Primary Outcomes (1)

• N-balances

  Total body nitrogen balance defined as difference between nitrogen intake and nitrogen appearance in urine, stool, and dialysate

  20 days

Study Arms (2)

Low normal pH (arterial pH 7.36-7.38)

ACTIVE COMPARATOR

Ammonium chloride or sodium citrate/citrate acid as needed to achieve the target pH

Drug: ammonium chloride or sodium citrate/citric acid

High Normal pH (arterial pH 7.44-7.46)

ACTIVE COMPARATOR

High Normal pH (7.44-7.46) with use of increasing doses of sodium bicarbonate up until the desired pH is achieved

Drug: Sodium citrate/citratic acid

Interventions

ammonium chloride or sodium citrate/citric acid DRUG

Dose dictated by changes in pH

Low normal pH (arterial pH 7.36-7.38)

Sodium citrate/citratic acid DRUG

dictated by pH

High Normal pH (arterial pH 7.44-7.46)

Eligibility Criteria

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

You may qualify if:

• Men and women from any ethnic/racial group \< 65 years.
• Treatment with CPD for 6 months and current treatment with APD for at least one month.
• Hemoglobin of at least 11.0 g/dl.
• Stable dose of erythropoietin treatment for at least the preceding three months.
• Subjects with normal nutritional status to mild malnutrition:
• Serum albumin \> 3.3 g/dl
• Relative body weight of 90-120% of the NHANES II median body weight for a given height, age range, gender and frame size.
• A normalized protein equivalent of total nitrogen appearance (nPNA) \> 0.80 g/kg actual body weight/day at the time of screening.
• D/P Cr between 0.48 and 0.81 on the PET performed at the time of the screen.
• Total (renal + peritoneal) weekly Kt/V urea \> 1.70 and creatinine clearance \> 50 L/wk/1.73 m2.
• No evidence of primary or secondary (viz., ischemic, neuropathic) myopathy

You may not qualify if:

• History of active cancer other than basal cell carcinoma.
• Symptomatic severe ischemic heart disease, uncontrolled severe dysrhythmias, uncontrolled congestive heart failure, poorly controlled hypertension, severe musculoskeletal disease, arthritis or amputation of the lower extremities.
• Insulin requiring diabetes mellitus.
• Patients who received L-carnitine or anabolic hormones (other than erythropoietin) within the previous 6 months.
• Use of CaCO3 as phosphate binder.
• Severe lung or liver disease, uncontrolled asthma, active vasculitis.
• Severe chronic infection or any other acute or chronic inflammatory or catabolic illnesses (e.g., active tuberculosis, AIDS, osteomyelitis).
• Psychosis, inability to give informed consent, evidence that patient will not comply with study protocol.
• Alcohol or other recreational drug abuse.
• Pregnancy (rare in CPD patients).
• Patients who are physically and/or psychologically incapable of undergoing the protocol.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

Related Publications (1)

• Mehrotra R, Bross R, Wang H, Appell M, Tso L, Kopple JD. Effect of high-normal compared with low-normal arterial pH on protein balances in automated peritoneal dialysis patients. Am J Clin Nutr. 2009 Dec;90(6):1532-40. doi: 10.3945/ajcn.2009.28285. Epub 2009 Oct 21.

  PMID: 19846545 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Acidosis

Interventions

Ammonium Chloride; Sodium Citrate; Citric Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Ammonium Compounds; Nitrogen Compounds; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Rajnish Mehrotra, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment with sodium citrate/citric acid or ammonium chloride chloride in each phase to achieve the desired arterial pH

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: September 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 5, 2017

Record last verified: 2017-08

Locations

US (1)