Risk Stratification and Goal-directed Volume Therapy

NCT ID: NCT01456702

Last Updated: 2013-12-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-31

Brief Summary

It is difficulte to evaluate risk patients and to find the ideal intraoperative volume management. It seems to be that ill patients benefit of a goal directed volume management. The aim of this study is to implement the guidelines on perioperative cardiovascular evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed protocoll for volume management.

Detailed Description

It is difficult in the majority of cases to estimate the correct intra-operative mass of fluid therapy for each patient und needs a high degree of clinical experience. Among circumstances and problems of surgery (kind of surgery, length of time, bleeding, loss of liquid via wound) and kind of anesthesia, are also the concomitant diseases of patients relevant for the action of all anesthetists. These concomitant diseases correct to detect and to deduce corresponding consequences calls likewise for high clinical experience. Furthermore, the pre-operative fasting is an important fact.

Considering all these influencing factors the anesthetist tends rather to apply to much volume during surgery, followed by much more problems in PACU and / or intensive care unit.

However, how much volume is correct for which patient during which kind of surgery? How could the investigators estimate the really intra vessel volume deficit? Which available parameters are helpful, which monitoring is useful? These questions confront daily every anesthetist.

Monitoring of clinical "traditional" factors such as diuresis, blood pressure und heart rate are from experience to inexactly. Actually exist in the experts no uniform opinion about the kind and amount of fluid administration, which to apply, as well as the adequate monitoring. The central venous pressure, a commonly used parameter, is falling more and more behind.

Cardiac filling pressures correlate bad with filling volume and are unsuitable parameters for fluid therapy. It seems that dynamic parameters such as stroke volume (SV) and stroke volume variation (SVV) are better markers. SV and SVV could be measured by usual invasive blood pressure via LiDCO- or FloTrac-Monitoring.

In the study the investigators would show, that it is necessary to optimize processes already in the anesthetic ambulance, to evaluate patients with theirs concomitant diseases correctly followed by an improvement of intra-operative processes.

With the help of questionnaire is to be better structured and classified the cardiac risk of patients in accordance with the actually ACC / AHA guidelines (8). Depending surgery risk, the development of intra-operative monitoring happens standardized preoperatively (NIBP vs. IBP vs. SVV via FlowTrac or LiDCO). The intra-operative fluid regime will be performing in the group of NIBP and IBP on the basis of standard operating procedures (SOP) as well as in the group of SVV on the basis of a targeted-volume protocol.

There are a lot of surgeries with an increased fluid turnover and increased risk for cardiac complication. This demonstrated study limits the kind of surgeries on orthopedic operations with different requirement of intra-operative volume.

Hypothesis The daily challenge of each anesthetic is the correctly estimate of volume status during surgery. Multiple factors such as concomitant diseases, pre-operative fluid fasting, anesthesia as well as circumstances of surgery inclusive bleeding risk have an important influence followed by difficult peri-operative management.

The aim of this study is the improvement of peri-operative fluid management due to process optimisation already in the anesthetic ambulance included cardiac risk factors of patients followed by intra-operative fluid protocol. Primary outcome parameters are administered fluid volume (including blood transfusion), and secondary measured by amount of blood loss, postoperatively frequency of PONV, delir as well as PACU and ICU stay.

The investigator believes that the investigators could reduce the intra-operative fluid volume as well as blood loss due to these process optimization followed by increase patient satisfaction. Furthermore, the investigators could possibly reduce the PACU and ICU stay.

Conditions

Fluid Volume Disorder

Keywords

SVV; hemodynamic monitoring; goal-directed volume therapie

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

control arm

volume therapy via standard operating procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention arm

goal-directed volume therapy due to svv in dependence of preoperative risk stratefication

Group Type: EXPERIMENTAL

risk stratification group

Intervention Type: PROCEDURE

goal-directed volume therapy due to svv measurement or volume therapy via standard operated procedures in dependence of cardiac risk factores

Interventions

risk stratification group

goal-directed volume therapy due to svv measurement or volume therapy via standard operated procedures in dependence of cardiac risk factores

Intervention Type: PROCEDURE

Other Intervention Names

svv group

Eligibility Criteria

Inclusion Criteria

• electiv orthopedic surgery with intermediate risk surgery
• signed informed consent
• >18 years

Exclusion Criteria

• No consent for the study
• Age < 18 years
• Emergency surgery
• Pregnant women
• Jehovah's Witnesses
• Myocardial infarction in the last 4 weeks
• High-risk cardiac factors
• GOLD IV

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Michael Sander

Vice Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Sander, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin

Locations

Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Countries

Germany

Central Contacts

Michael Sander, MD

Role: CONTACT

Phone: +49-30-450531

Email: michael.sander@charite.de

Facility Contacts

Michael Sander, MD

Role: primary

Other Identifiers

VoMo

Identifier Type: -

Identifier Source: org_study_id