Cristalloid versus colloid in patients with severe sepsis and septic shock

ISRCTN	ISRCTN25391663
DOI	https://doi.org/10.1186/ISRCTN25391663
Protocol serial number	N/A
Sponsor	University Medical Center Utrecht (The Netherlands)
Funder	University Medical Centre Utrecht, Department of Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof L.P.H. Leenen
Scientific

University Medical Centre Utrecht
Department of Surgery HP G04.228
P.O. Box 85500
Utrecht
3584 CX
Netherlands

Phone	+31 (0)30 2509882
Email	lleenen@chir.azu.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	KRISCOLL (in Dutch: KRIStalloid versus COLLoid)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	60
Key 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.
Key exclusion criteria	Patients under the age of 18 years and patients with a sensitivity to starch-products.
Date of first enrolment	14/11/2005
Date of final enrolment	31/12/2007

University Medical Centre Utrecht

Utrecht
3584 CX
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan