Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock

Patients with severe infection can develop very low blood pressure. There are many mechanisms leading to this, and one of them appears to involve a hormone called vasopressin. In children as compared to adults, the mechanism and response to low blood pressure are different for reasons that are not clear. One possibility is the difference in the production and/or response to vasopressin. Vasopressin has become part of the treatment of children with low blood pressure in the setting of severe infection, when other treatment has failed, but its use is on the basis of animal and adult studies. The exact timing and dose is uncertain.

In this research study, the patients will receive standard treatment for sepsis and septic shock, and the investigators will measure the blood levels of vasopressin and a related compound called copeptin (both are required to understand the mechanism of control involved). Blood will need to be taken from patients without any sepsis so as to be able to compare the values in health and in sickness. The patient groups the investigators have chosen for this are those children who will have blood taken anyway as part of their routine care. The aim of this study is to develop an understanding of the body's hormonal response (with respect to vasopressin) to severe infection in children. The long-term aim is to improve the care of critically ill children with severe infection by using the most appropriate dose of vasopressin at the most appropriate time.

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Key information

Conditions

Sepsis Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

1 day–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KK Women's and Children's Hospital

Singapore, 229899

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Control Group:

Neonates admitted for neonatal jaundice requiring phototherapy
Previously well patients admitted for elective gastrointestinal endoscopy, patients admitted for non-specific abdominal pain and
Pre-operative patients for circumcision, inguinal hernias and chronic orthopaedic conditions

Study Group:

The investigators will also enroll children with sepsis and septic shock
Sepsis will be defined as proposed by the International pediatric sepsis consensus conference.
Children will be recruited into the septic shock group if they have sepsis and features of cardiovascular organ dysfunction as defined by the same consensus conference.

Exclusion criteria

Neonates weighing less than 2.5 kg
Neonates less than 36 weeks gestation
Children more than 16 years of age
Patients with a history of congenital heart disease
Patients with chronic renal impairment
Patients with chronic liver impairment
Patients on active chemotherapy
Patients on chronic mineralocorticoids or glucocorticoids therapy
Patients on long-term diuretic therapy
Patients with central nervous system tumours
Patients with developmental delay

Treatment and study plan

Primary outcomes

Vasopressin and copeptin levels

Time frame: First 5 days of admission

Sponsors and collaborators

Lead sponsor

Jan Hau Lee

Other Gov

Collaborators

National Medical Research Council (NMRC), Singapore

Registry information

Acronym: VaCoSS

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Jun 16, 2008
Registry last updated: Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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