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High exclusion rate
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Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients?
The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the "traditional" fluids, ie the current regime.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard monitoring. Initial optimization of fluid status is performed by pulse, BP and anaesthesiologist assessment with Ringer acetate. Followed by an infusion of 10ml/kg/t Ringer acetate. Urinary output and blood pressure is used as a surrogate parameter: the infusion rate is increased by a fall in blood pressure or urine output <0.5ml/kg/t. Bleeding replaced with HES 1:1, otherwise see table for fluid therapy page 9. Vasoactive agents (noradrenaline / phenylephrine) is given if the anesthesiologist considers this necessary. Postoperative give 1000ml Glucose 5%. HES or Ringer when low blood pressure, eventually noradrenaline as vasoactive agent. | |
| Goal directed fluid therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal directed fluid therapy guided by LiDCOrapid | Procedure | Standard monitoring. The patient is connected to the LiDCOrapid monitor via an arterial line placed in a.radialis. A bolus of 500 ml Ringer acetate is given before anesthesia. If the stroke volume (SV) increases more than 10%, repeat the procedure until the SV is not increasing. After that, induction of anesthesia. Maintenance fluid is given as Ringer acetate 2ml/kg/t. Continuous monitoring of stroke volume variation (SVV). If SVV> 10%, give a fluid bolus 6ml/kg Ringer acetate. Repeat until SVV <10%. Bleeding is being replaced 1:1 with hydroxyethyl starch. SAG by bleeding >1000ml. By fall in blood pressure and SVV <10%, start vasoactive treatment with epinephrine. Postoperative is given Glucose 5% 80ml/h. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | 5 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | 3 month after surgery | |
| Complications until discharge and readmission within 30 days | 3 month after surgery | |
| Mortality within 30 days and 3-month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ib Jammer, MD | Helse Bergen HF, Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital, Department of Anesthesia and Intensive Care | Oulu | 90029 | Finland | |||
| Haukeland University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26203353 | Derived | Jammer I, Tuovila M, Ulvik A. Stroke volume variation to guide fluid therapy: is it suitable for high-risk surgical patients? A terminated randomized controlled trial. Perioper Med (Lond). 2015 Jul 22;4:6. doi: 10.1186/s13741-015-0016-x. eCollection 2015. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 3 month after surgery |
| Renal function | defined by RIFLE criteria | 5 days after surgery |
| Vasoactive agents need | Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period. | 3 month after surgery |
| Bergen |
| 5021 |
| Norway |
| Stavanger Universityhospital, Division for medical service, anesthesia and intensive care | Stavanger | 4011 | Norway |