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Risk Stratification and Goal-directed Volume Therapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01456702
First received: September 29, 2011
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Fluid Volume Disorder
Procedure: risk stratification group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Influence of Pre-operative Risk Stratefiction and Intraoperaitve Monitoring on Perioperative Volume Therapy and Postoperative Outcome

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • intra- and postoperative volume [ Time Frame: surgical time + treatment time until discharched to the ward or a maximum of 10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • treatment time in PACU, ICU, anesthetic recovery room [ Time Frame: admission on PACU, ICU and anesthetic recovery room until a maximum of 10 hours ] [ Designated as safety issue: No ]
  • incidence of delirium and PONV [ Time Frame: admission on ICU, PACU, anesthetic recovery room until discharge to the ward or a maximum of 10 hours ] [ Designated as safety issue: No ]
  • need of blood tranfusions [ Time Frame: intra- and postoperative treatment time with a maximum of 10 hours postoperative ] [ Designated as safety issue: No ]
  • incidence of vasopressors [ Time Frame: intra- and postoperative treatment time until a maximum of 10h postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control arm
volume therapy via standard operating procedure
Experimental: intervention arm
goal-directed volume therapy due to svv in dependence of preoperative risk stratefication
Procedure: risk stratification group
goal-directed volume therapy due to svv measurement or volume therapy via standard operated procedures in dependence of cardiac risk factores
Other Name: svv group

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456702

Contacts
Contact: Michael Sander, MD +49-30-450531 ext 052 michael.sander@charite.de

Locations
Germany
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Contact: Michael Sander, MD    +49-30-450 531 ext 052    michael.sander@charite.de   
Sub-Investigator: Alexandra Lau, MD         
Sub-Investigator: Michael Krämer, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Michael Sander, MD Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
  More Information

No publications provided

Responsible Party: Michael Sander, Vice Chair, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01456702     History of Changes
Other Study ID Numbers: VoMo
Study First Received: September 29, 2011
Last Updated: December 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
SVV
hemodynamic monitoring
goal-directed volume therapie

ClinicalTrials.gov processed this record on November 20, 2014