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Acidosis clinical trials

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NCT ID: NCT05225467 Completed - Diabetes Mellitus Clinical Trials

Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study'

DKAP
Start date: March 15, 2022
Phase:
Study type: Observational [Patient Registry]

Rationale: During perioperative period, prolonged starvation, surgical stress, acute complications (e.g. infection) and medication changes all promote ketone generation, therefore increasing the risk of ketoacidosis. At present, there is no literature concerning the ketone production in patients undergoing cardiac surgery, regardless of the diabetes status. Objectives: The objectives of this study are to explore the change in blood ketone level during the perioperative period in patients with and without diabetes, to observe the incidence of perioperative ketoacidosis, and to investigate therapy and outcome of patients with perioperative ketoacidosis.

NCT ID: NCT05147051 Completed - Metabolic Acidosis Clinical Trials

Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients

Start date: June 16, 2021
Phase: Phase 2
Study type: Interventional

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 with various underlying diseases. Metabolic acidosis has a negative impact on the cardiovascular, respiratory, digestive, nervous, excretory, hematological, endocrine, musculoskeletal and immune systems and is associated with unfavourable outcomes. Reamberin® is a solution of disubstituted sodium salt of succinic acid, which has an alkaline reaction and succinate is capable to integrate into the Krebs cycle and restore energy metabolism in the cell. The aim of the present study is to evaluate the efficacy and safety of meglumine sodium succinate at a dose of 500 to 3000 ml in critically ill patients with metabolic acidosis and choose the optimal volume of its solution for the correction of metabolic acidosis in critically ill patients.

NCT ID: NCT04975906 Completed - Critical Illness Clinical Trials

The Threshold of Serum Anion Gap as a Screening Tool for Organic Acidosis

Start date: July 1, 2017
Phase:
Study type: Observational

Background: The serum anion gap (AG) is commonly used as a screening tool for acid-base disorders. With modern laboratory techniques using ion-selective electrodes to measure the main electrolyte components of the AG, our definition high AG (HAGMA) should be reviewed. Aim: This study aims to assess the diagnostic value of AG and to determine a diagnostic threshold for HAGMA in a high-prevalence clinical setting. Method: Computerized extraction of anonymised data from electronic medical records was performed. A pre-defined criteria included all inpatients of an acute-care hospital who had measurements for organic acids (lactate, ketone or salicylate) paired with a serum urea, electrolyte and creatinine panel.

NCT ID: NCT04953013 Completed - Clinical trials for Metabolic Acidosis; Critically Ill Patients; Organ Dysfunction

Risk Potential for Organ Dysfunction Associated With Sodium Bicarbonate Therapy (SBT) in Critically Ill Patients

Start date: August 1, 2019
Phase:
Study type: Observational

This study aimed to investigate whether hemodynamic status before SBT contributed to the effect of sodium bicarbonate infusion on the risk of neonatal organ dysfunction and mortality in critically ill patients with early metabolic acidosis in ICU.

NCT ID: NCT04948138 Completed - MELAS Syndrome Clinical Trials

Glutamine Supplement in MELAS (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like Episodes) Syndrome

Start date: June 28, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assesses the efficacy of oral supplementation with glutamine over three months on several amino acids and lactate concentration measured in cerebrospinal fluid and cerebral lactate measured by magnetic resonance spectroscopy.

NCT ID: NCT04926740 Completed - Clinical trials for Diabetic Ketoacidosis

Intravenous Fluids in Adults With Diabetic Ketoacidosis in the Emergency Department

BRISK-ED
Start date: October 12, 2021
Phase: N/A
Study type: Interventional

Diabetes mellitus is a common chronic disease. It is estimated that up to 40% of adults may develop diabetes in their lifetime. Patients with poorly controlled blood sugars often visit the emergency department for treatment of potentially dangerous and life-threatening complications of diabetes, including "diabetic ketoacidosis" (DKA), a condition where the body does not have enough insulin or cannot effectively use the insulin that is produced. As a result, the body produces a chemical called "ketones" as another source of energy, which increase the acid levels of blood and impairs organ function throughout the body. In the emergency department, patients with DKA are usually treated with insulin and large amounts of intravenous fluid. Recent research suggests the fluid type used may be important in treating DKA. Normal saline (0.9% sodium chloride) is the most commonly used intravenous fluid in treating DKA, but it has a very high concentration of chloride and can lead to additional acid production when given in large volumes. Ringer's lactate is another type of intravenous fluid that more closely matches the chemistry of fluid in our bodies and in theory, does not increase the acidity of blood. While there may be benefits to giving Ringer's lactate instead of normal saline, past studies have included very few patients and thus, definite recommendations on preferred fluid type still cannot be made. This study's research question is: In adults with DKA, does giving Ringer's Lactate result in faster resolution of DKA compared to normal saline? The investigators hypothesize that patients who are given Ringer's Lactate will have faster resolution of DKA. If the hypothesis is correct, results will provide scientific proof that current diabetic ketoacidosis guidelines should change with respect to fluid choice. In this study, patients with DKA presenting to the emergency department will be randomly assigned to receive either normal saline or Ringer's Lactate. As this is an exploratory (pilot) study, the main goal is to ensure that a larger study will be practical and feasible on a scale involving multiple emergency departments across Canada. Completion of a larger study across multiple sites with more patients will improve our understanding of how fluid choice influences patient-important outcomes such as faster resolution of DKA (meaning patients can leave hospital sooner), fewer admissions to the intensive care unit, fewer deaths and fewer cases of permanent kidney damage. A total of 52 participants (26 per group) will be recruited for this pilot trial. This pilot study will assess the practicality of enrolling patients in London and help identify barriers and problems with running a larger trial. The overall goal is to determine if Ringer's Lactate will resolve DKA faster than normal saline. If this is true, patients may spend less time in the hospital, which benefits both individual patients and the healthcare system overall. If this hypothesis is correct, findings could provide high-level proof to change current practice guidelines and affect DKA management globally.

NCT ID: NCT04904705 Completed - Clinical trials for Cognitive Orientation

The Effect of the Cognitive Orientation to Daily Occupational Performance Approach for Children With Organic Acidemia

Start date: June 22, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to research the effect of Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) on daily life activities, quality of life and participation in children with organic acidemia. The hypotheses of the study are as follows: - Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to children with organic acidemia has no effect on daily life activities. - Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to children with organic acidemia has no effect on quality of life. - Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to children with organic acidemia has no effect on participation.

NCT ID: NCT04604548 Completed - Clinical trials for Mitochondrial Diseases

The KHENEREXT Study

Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-centre study in subjects with a genetically confirmed mitochondrial deoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation who completed study KH176-202. In the KH176-203 study subjects will be receiving KH176 100 mg BID or KH176 50 mg bid in die (BID) (as determined by the investigator based on safety / tolerability considerations) for a year, thereby ensuring continued treatment with KH176 after study KH176-202. A final follow-up visit is scheduled 4 weeks after the intake of the last dose of study medication for patients not rolling over into the compassionate use program. Primary safety data and secondary efficacy (endpoint) data will be monitored and reviewed every three months by an independent Data Safety Monitoring Board (DSMB) to evaluate potential risks and benefits.

NCT ID: NCT04600323 Completed - Clinical trials for Chronic Kidney Disease

Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD

Start date: February 1, 2021
Phase: Early Phase 1
Study type: Interventional

This is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with CKD stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.

NCT ID: NCT04231045 Completed - Acidosis Clinical Trials

The Impact of the pH on Cardiac Function in the Critically Ill Patient

Start date: May 2, 2018
Phase:
Study type: Observational [Patient Registry]

Study Title: The Impact of the pH on cardiac function in the critically ill patient Sponsor: King's College Hospital NHS Foundation Trust Chief Investigator: Dr Sancho Rodríguez-Villar IRAS Number: 227870 Hypothesis: Titration studies in animals with normal cardiac function show that a reduction in blood pH (and presumably that of the intracellular and interstitial compartments) from the normal level of 7.40 to 7.20 is associated with a rise in cardiac output. However, when blood pH is less than 7.20, cardiac output is reduced. Similar studies in humans with or without normal cardiac function have not been done, and yet blood pH at which aggressive treatment is recommended has been set at 7.20 based solely on animal experiments. The investigators hypothesize that a change in blood pH in humans will also affect cardiac function, but the level of blood pH at which this is observed might be similar or different in humans. In addition, the presence or absence of underlying cardiac disease and the type of acid-base abnormality present might modify the response of the heart to changes in blood pH. Primary Objectives: 1. Assess whether there are significant changes in cardiac function associated with changes in blood pH. 2. Relate the changes in cardiac function to the presence or absence of underlying cardiac disease. Study Design: A prospective multicenter observational study in 6 ICU´s (between two Trusts). During a year study period, a minimum of 300 patients will be recruited.