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

NCT ID: NCT00698048

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Controls

No interventions assigned to this group

2

Sepsis

No interventions assigned to this group

3

Septic Shock

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role: collaborator

Jan Hau Lee

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jan Hau Lee

Dr Lee Jan Hau

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jan Hau Lee, MRCPCH(UK)

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

NIG07nov002

Identifier Type: -

Identifier Source: org_study_id