Cristalloid vs. colloid in patients with severe sepsis and septic shock.

Cristalloid versus Colloid resuscitation in patients with severe sepsis or septic shock; effects on extravascular lung water en tissue oxygen tension.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21828

Enrollment

Registered

2005-11-11

Start date

2005-11-14

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe sepsis or septic shock.

Interventions

Subjects are assigned to be resuscitated either with cristalloids (sodiumchloride 0,9%) or cristalloid combined with colloids (polyhydroxyethylstarch 10%) untill rescusitation endpoints have been esta

Eligibility

Inclusion criteria

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

Exclusion criteria: Patients under the age of 18 years and patients with a sensitivity to starch-products.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactL.P.H. Leenen

University Medical Center Utrecht (UMCU), Department of Surgery, HP G04.228, P.O. Box 85500

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)