Contact information
Type
Scientific
Primary contact
Prof L.P.H. Leenen
ORCID ID
Contact details
University Medical Centre Utrecht
Department of Surgery HP G04.228
P.O. Box 85500
Utrecht
3584 CX
Netherlands
+31 (0)30 2509882
lleenen@chir.azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
KRISCOLL (in Dutch: KRIStalloid versus COLLoid)
Study hypothesis
To demonstrate whether there is difference in tissue oxygen tension and extravascular lung water while patients are being resuscitated with cristalloids or colloids combined with cristalloids.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Sepsis, Septic shock
Intervention
Subjects are assigned to be resuscitated either with cristalloids (sodium chloride 0.9%) or cristalloid combined with colloids (polyhydroxyethylstarch 10%) until resuscitation endpoints have been established.
Endpoints are an intrathoracal blood volume of >850 ml/m^2, a mean arterial pressure of >70 mmHg and a cardiac index of >3.0 l/min/m^2.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The relation between the resuscitation regime and the tissue oxygen tension.
Furthermore the relation between the resuscitation regime and the amount of extravascular lung water, as well as the relation between the amount of extravascular lung water and the tissue oxygen tension.
Secondary outcome measures
1. Subcutaneous temperature
2. Laboratory findings: hemoglobin, hematrocrite, albumin, arterial and venous blood gasses
3. Hemodynamic parameters: cardiac output, VO2, DO2
4. Respiratory parameters: PEEP, PaO2/FiO2 ratio; inotropes
Overall trial start date
14/11/2005
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Sever sepsis or septic shock (according to the criteria of the American College of Chest Physicians/Society of Critical Care Medicine) in a mechanically ventilated ICU patient.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Patients under the age of 18 years and patients with a sensitivity to starch-products.
Recruitment start date
14/11/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht
Utrecht
3584 CX
Netherlands
Funders
Funder type
University/education
Funder name
University Medical Centre Utrecht, Department of Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary