No registrations found.
ID
Source
Brief title
Health condition
Severe sepsis or septic shock.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The relation between the resuscitation regime and the tissue oxygen tension.
Furthermore the relation between the resuscitation regime and the amount of extravascular lungwater, as well as the relation between the amount of extravascular lungwater and the tissue oxygen tension.
Secondary outcome
1. Subcutaneous temperature;
2. Labaratory findings: hemoglobine, hematrocrite, albumine, arterial and venous bloodgasses;
3. Hemodynamic parameters: cardiac output, VO2, DO2;
4. Respiratory parameters: PEEP, PaO2/FiO2 ratio; inotropes.
Background summary
N/A
Study objective
To demonstrate wether there is difference in tissue oxygen tension and extravascular lung water while patients are being resuscitated with cristalloids or colloids combined with cristalloids.
Study design
N/A
Intervention
Subjects are assigned to be resuscitated either with cristalloids (sodiumchloride 0,9%) or cristalloid combined with colloids (polyhydroxyethylstarch 10%) untill rescusitation endpoints have been established.
Endpoints are an intrathoracal blood volume of > 850 ml/m2, a mean arterial pressure of > 70 mmHg and a cardiac index of > 3.0 l/min/m2.
Department of Surgery, HP G04.228,
P.O. Box 85500
L.P.H. Leenen
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2509882
lleenen@chir.azu.nl
Department of Surgery, HP G04.228,
P.O. Box 85500
L.P.H. Leenen
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2509882
lleenen@chir.azu.nl
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.
Exclusion criteria
Patients under the age of 18 years and patients with a sensitivity to starch-products.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL460 |
| NTR-old | NTR501 |
| Other | : N/A |
| ISRCTN | ISRCTN25391663 |