Symptoms and General Pathology

All Conditions

Neoplasms

Nutritional and Metabolic Diseases

Nervous System Diseases

Gland and Hormone Related Diseases

Syndrome

Neoplasm Metastasis

Hyponatremia

Inappropriate ADH Syndrome

Water-Electrolyte Imbalance

Metabolic Diseases

Pituitary Diseases

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Medical Department

In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in oncology patients was developed. Since it is hypothesised that the adherence to the SEOM algorithm is not 100%, the current retrospective non-interventional study will investigate the perceived and actual adherence of participating centres to the SEOM algorithm and its impact on patient outcomes

An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain

An Observational, Retrospective Study to Describe the Extent of Adherence to the Spanish Society of Medical Oncology Algorithm for the Treatment of Hyponatraemia Secondary to SIADH in Oncology Patients in Spain (ALGA)

Adherence to the algorithm will be evaluated using a pre-defined decision tree that will be provided in the electronic case report form (eCRF) and will be completed by the investigator

Improvement is defined as a change in the baseline sodium level category (mild, moderate or severe) from a worse category to a better category or eunatraemia. Note that the time to improvement of sodium levels was defined as the first date/time of improvement of sodium levels - date/time of collection of serum sodium levels at baseline (for patients where there was an improvement in sodium levels) or as the final date/time of collection of serum sodium levels - date/time of collection of serum sodium levels at baseline (for patients that did not achieve an improvement in sodium levels \[censored patients\]).

Otsuka Pharmaceutical Europe Ltd

Any untoward medicinal occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment (Directive 2001/83/EC amended by Directive 2010/ 84/ EU). An AE can therefore be any unfavourable and unintended sign (e.g., abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not it is considered causally related to the medicinal product.

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level \<135 mmol/L)

Oncology Patients With Hyponatraemia

Age, Continuous

Sex: Female, Male

Spain

Region of Enrollment

Weight

Height

Body Mass Index

Recruitment problems leading to smaller sample size than expected (70 patients vs 100). A priori, the impact on precision was considered acceptable (95% confidence interval equal to ± 10.0% with 100 patients vs ± 11.7% with 70 patients).

Number of Patients Managed According to the SEOM Algorithm (as a Result Adherence to the Algorithm Will be the % of These Patients Among the Total Number of Patients)

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH according to the SEOM algorithm.

Participants Treated According to SEOM Algorithm

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH not according to the SEOM algorithm.

Participant NOT Treated According to SEOM Algorithm

The overall number of patients analysed represents the number of participants for which the data (time in days) was available. As a retrospective chart review, there were some missing data in this outcome measure (date of improvement in this case)

Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH according to the SEOM algorithm and who were candidate for or actually in chemotherapy treatement when the hyponatremia episode occurred.

Subjects With Chemotherapy Treated as Per SEOM Algorithm

Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH NOT according to the SEOM algorithm and who were candidate for or actually in chemotherapy treatement when the hyponatremia episode occurred

Subjects With Chemotherapy NOT Treated as Per SEOM Algorithm

In this analysis, only the 22 patients who were candidate for chemotherapy during the study period were included, this explains the difference with the total number of participants.

Time to Initiation or Re-initiation of Chemotherapy (Since the Start of the Hyponatraemia Episode) in Patients Candidate for Chemotherapy Who Were and Were Not Treated in Adherence With the SEOM Algorithm.

Length of Hospitalisation (Measured From the Start of the Hyponatraemia Episode to Discharge) for Patients Who Were and Were Not Treated in Adherence With the Algorithm

The overall number of patients analysed represents the number of participants for which the data (time in hours) was available. As a retrospective chart review, there were some missing data in this outcome measure (time of improvement in this case)

Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours)

Overall Study

Head and Neck Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Adjuvants, Anesthesia

Psychotropic Drugs

Platelet Aggregation Inhibitors

Anesthetics

Oxycodone

Dexmedetomidine

Midazolam

Propofol

Sevoflurane

Hypnotics and Sedatives

Etomidate

Head and neck tumor resections were performed in general anesthesia. Midazolam and etomidate or propofol were used in introduction and then anesthesia was maintenance with sevoflurane. Patients received intravenous continuous infusion of oxycodone as an analgesic component and sedatives (propofol/dexmedetomidine/midazolam) during analgosedation in ICU.

Infusion Intravenous

Agnieszka Bienert, MSC, PhD

Edmund Grzeskowiak, MSC, PhD

Treatment personalization could ensure better outcome than standard procedures. It is particularly important in intensive care units where patients received many drugs and procedures. Their health status can change very fast. The oncologic patients treated in intensive care units are a special group of patients. Factors related to cancer influence extra their health status. The aim of this study is population pharmacokinetic-pharmacodynamic analysis drugs that are routinely used during an analgosedation in ICU oncologic patients. Analgosedation is monitored by drugs plasma concentration, the depth of sedation (bispectral index) and vital parameters like: systolic and diastolic blood pressure, mean arterial pressure, heart rate. Moreover, the TNM Staging System, biochemical parameters, The American Society of Anesthesiologists (ASA) physical status classification will be checked like potential factors influencing on pharmacokinetics and pharmacodynamics drugs used in the study.

The oncologic patients are qualified to head and neck tumor resection in general anesthesia. The anesthesia introduction is performed with single dose of midazolam, fentanyl, rocuronium and propofol/etomidate. Sevoflurane is used in anesthesia maintenance. Patients are transported to ICU after operation. Then they are kept for several hours in analgosedation. All used drugs are given by intravenous continuous infusion. Oxycodone is an analgesic component of analgosedation. Midazolam, dexmedetomidine and/or propofol are used as sedatives (2-3 drugs in every patient). Whole blood samples (2.0 ml) are collected during the study to measure drugs concentrations - 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation. Vital parameters and bispectral index are monitored during analgosedation and 6 hours after the infusion cessation and noted every 15-60 minutes.

Pharmacotherapy Personalization of Cancer Patients

Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques

pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available

Continuous measurement of the depth of sedation using bispectral index during analgosedation in intensive care unit.

Measurements of oxycodone and noroxycodone plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.

Measurements of dexmedetomidine plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.

Measurements of midazolam and alfa-hydroxymidazolam plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.

Measurements of propofol plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.

Measurements of systolic blood pressure during analgosedation in intensive care unit.

Measurements of diastolic blood pressure during analgosedation in intensive care unit.

Measurements of heart rate during analgosedation in intensive care unit.

Measurements of mean arterial pressure during analgosedation in intensive care unit.

The Greater Poland Cancer Centre

Medical University of Gdansk

Poznan University of Medical Sciences

Full Professor

Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil.

To provide detailed information about cost and effectiveness of FDG-PET in multiple oncological diseases, such as Lymphoma, lung cancer and esophageal cancer.

Cost-effectiveness of FDG-PET

Estudo de Custo-efetividade Para o Sistema único de Saúde - SUS Sobre o Exame de Metabolismo de Glicose Marcada Com Flúor-18 Pela Tomografia de emissão de pósitron-PET

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain	NCT02548845	Hyponatremia Syndrome of Ina...		18 Years -	Otsuka Pharmaceutical Europe Ltd
Pharmacotherapy Personalization of Cancer Patients	NCT04866498	Head and Neck N... Oncologic Patie...	Infusion Intrav...	18 Years -	Poznan University of Medical Sciences
Cost-effectiveness of FDG-PET	NCT01438164	Oncologic Patie...		13 Years -	University of Sao Paulo

Spots Global Cancer Trial Database for oncologic patients