SepsisVaCoSSNCT00698048
Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock
An observational study of Sepsis and Septic Shock, run by Jan Hau Lee at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 136 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between one day of age and sixteen years old.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Sepsis, Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Controls | |
| 2 | Sepsis | |
| 3 | Septic Shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressin and copeptin levels
Measured: First 5 days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Hau Lee
- Sponsor type
- Other government
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor-investigator, Jan Hau Lee, KK Women's and Children's Hospital
- Investigators
- Jan Hau Lee, MRCPCH(UK), Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698048
- Sponsor's protocol ID
- NIG07nov002
- Acronym
- VaCoSS
- Status last verified
- Sep 2015
- First submitted
- 12 Jun 2008
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT00698048
- Acronym / sponsor ID
- VaCoSS / NIG07nov002
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic Shock, Vasopressin, Copeptin, Paediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Jan Hau LeeOther government
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Aug 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Controls |
| 2 | – | –Sepsis |
| 3 | – | –Septic Shock |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between one day of age and sixteen years old.
Key inclusion criteria (8 listed)
- 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
- The investigators will also enroll children with sepsis and septic shock
- Sepsis will be defined as proposed by the International pediatric sepsis consensus conference.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vasopressin and copeptin levels
Time frame: First 5 days of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Hau Lee, MRCPCH(UK) principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Jan Hau Lee at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasopressin and copeptin levels (time frame: First 5 days of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.