Clinical trials: Acid-Base Imbalance
Trauma, Hemorrhagic Shock
Phase 2c Dose Comparison Study of MP4OX in Trauma
MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen…
- Conditions
- Trauma, Hemorrhagic Shock, Lactic Acidosis
- Trial name
- NCT01973504
- Testing
- MP4OX, Control
- Where
- 31 sites in Australia, Belgium and 9 more
- Sponsor
- Sangart
Metabolic Acidosis
Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients
An acid-base imbalance, called metabolic acidosis (acid-base disorder lasting from several minutes to several days, caused by a decrease in serum bicarbonate ion (HCO3) concentration), is often observed in critically ill patients…
- Trial name
- NCT05147051
- Testing
- Meglumine Sodium Succinate
- Where
- 6 sites in Russia
- Volunteers
- 140 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Acidosis
Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels.
- Trial name
- NCT02809183
- Testing
- TRC101
- Where
- 5 sites in Bulgaria, Georgia
- Volunteers
- 135 people
- Sponsor
- Tricida, Inc.
Distal Renal Tubular Acidosis
Study Evaluating Subjects With Distal Renal Tubular Acidosis
This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in pediatric and…
- Trial name
- NCT03644706
- Testing
- ADV7103
- Where
- 8 sites in United States, Canada
- Volunteers
- 3 people
- Sponsor
- Advicenne Pharma
Metabolic Acidosis, Chronic Kidney Disease
Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.
- Trial name
- VALOR-CKD (NCT03710291)
- Testing
- TRC101
- Where
- 203 sites in United States, Albania and 32 more
- Volunteers
- 1,480 people
- Sponsor
- Tricida, Inc.
Alzheimer's Disease
AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)
The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months.
- Trial name
- ALERT (NCT01211782)
- Testing
- caprylic triglyceride, long-chain triglyceride
- Where
- United States
- Sponsor
- Cerecin
Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2
The BRIGHT Study (Device Name: HALO System)
The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by…
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus, Ketoacidosis, Diabetic
- Trial name
- NCT07745998
- Testing
- The HALO System
- Volunteers
- 12 people
- Sponsor
- Indigo Diabetes NV
Diabetes Mellitus, Diabetes Mellitus, Type 1
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Ketoacidosis, Diabetic
- Trial name
- NCT05597605
- Testing
- The SHINE SYSTEM
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 6 people
- Sponsor
- Indigo Diabetes NV
Time Restricted Feeding
Effect of 14:10 Time-Restricted Eating on Body Weight and Metabolic Markers
The purpose of this study is to investigate the effect of engaging in time restricted eating schedule on body weight, blood glucose, and ketones (breath acetone) in individuals with obesity.
- Trial name
- NCT04492930
- Testing
- 14:10 Regimen, 12:12 Regimen
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Jenny Craig, Inc.
Ketosis, Epilepsy
Market Research - Acceptability Study for New MCT Fat Products
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.
- Conditions
- Ketosis, Epilepsy, Fatty Acid Oxidation Disorder, Malabsorption
- Trial name
- NCT04309214
- Testing
- MCT fats
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Dr. Schär AG / SPA
Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease
Clinical Stabilization of Hypercapnia: NIPPV v HVNI
This study will evaluate the ability of High Velocity Nasal Insufflation [HVNI] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation [NIPPV].
- Conditions
- Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis
- Trial name
- HYPERACT (NCT04709562)
- Testing
- High Velocity Nasal Insufflation (HVNI), Noninvasive Positive Pressure Ventilation (NIPPV)
- Where
- 7 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Vapotherm, Inc.
Alzheimer's Disease
Tricaprilin in Mild to Moderate Alzheimer's Disease
The purpose of this study is to evaluate the safety, tolerability and effectiveness of tricaprilin administered once a day for ninety days in subjects with mild to moderate, probable Alzheimer's disease.
- Trial name
- NCT00142805
- Testing
- Tricaprilin
- Where
- 25 sites in United States
- Volunteers
- 152 people
- Sponsor
- Cerecin
Healthy Volunteers and Diabetes Participants
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
This is a Phase 1/2 randomized study of oral doses of PAL-119 in healthy volunteers and participants with diabetes.
- Trial name
- NCT07901595
- Testing
- PAL-119
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Paulex Bio Inc.
Acidosis
Safety of D-lactate Producing Probiotics
In this study the investigators want to test the safety of D-lactate producing probiotics in babies from birth to 1 month of age.
- Trial name
- NCT01119170
- Testing
- Starter formula, starter formula with D-lactate producing probiotics
- Where
- Greece
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Propionic Acidemia
A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).
- Trial name
- NCT05130437
- Testing
- mRNA-3927
- Where
- 22 sites in United States, Canada and 6 more
- Volunteers
- 50 people
- Sponsor
- ModernaTX, Inc.
Hypoxia, Ketosis
Ketone Esters for Optimization of Cognitive Performance in Hypoxia
This study will investigate the effects of ketone ester drinks on cognitive performance in hypoxia.
- Trial name
- NCT03659825
- Testing
- Ketone Ester, Hypoxic exposure
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- HVMN Inc
Metabolic Acidosis
Long-term Safety Extension to Study TRCA-301
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study…
- Trial name
- NCT03390842
- Testing
- TRC101
- Where
- 29 sites in United States, Bulgaria and 5 more
- Volunteers
- 196 people
- Sponsor
- Tricida, Inc.
Dyspnea, Lactic Acidosis
Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline
The study will evaluate the impact of high velocity therapy (HVT) on reduction of work of breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery from a Wingate-type Exercise test.
- Conditions
- Dyspnea, Lactic Acidosis, Muscle, Breathlessness
- Trial name
- NCT05984186
- Testing
- High Velocity Therapy
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Vapotherm, Inc.
Ketogenic Dieting, Ketosis
Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.
- Trial name
- NCT04130724
- Testing
- Blood ketone testing, Breath ketone testing
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Readout, Inc.
Ketosis, Epilepsy
Market Research - Acceptability Study for a Range of MCT Products
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.
- Conditions
- Ketosis, Epilepsy, Ketogenic Diet, Fatty Acid Oxidation Disorder
- Trial name
- NCT04309149
- Testing
- MCT fats
- Where
- 2 sites in United Kingdom
- Volunteers
- 12 people
- Sponsor
- Dr. Schär AG / SPA