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

NCT00698048 | Completed

• 1 other identifier: NIG07nov002
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Septic Shock; Vasopressin; Copeptin; Paediatrics

Outcome Measures

Primary Outcomes (1)

• Vasopressin and copeptin levels

  First 5 days of admission

Study Arms (3)

1

Controls

2

Sepsis

3

Septic Shock

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between one day of age and sixteen years old.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jan Hau Lee: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Sepsis; Shock, Septic; Diabetes Insipidus

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Hau Lee, MRCPCH(UK)

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Lee Jan Hau

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

SG (1)