Clinical Trial Results:
Perioperative Goal Directed Fluid Therapy during Esophageal Resection. A prospective randomized controlled open multi-centre trial to study the effect on postoperative complications
Summary
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EudraCT number |
2011-000254-39 |
Trial protocol |
SE |
Global end of trial date |
30 Apr 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Apr 2024
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First version publication date |
30 Apr 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2011-07-01 korr 121213
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01416077 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Region Östergötland
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Sponsor organisation address |
Universitetssjuhuset, Linköping, Sweden, 58183
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Public contact |
Lena Nilsson, Department of Anesthesia and Intensive Care, 46 0101031838, lena.nilsson@regionostergotland.se
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Scientific contact |
Lena Nilsson, Department of Anesthesia and Intensive Care, 46 0101031838, lena.nilsson@regionostergotland.se
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Apr 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Oct 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Apr 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To test whether intraoperative fluid and catecholamin administration steered by stroke volume optimization measured by "pulse contour analysis" will result in fewer postoperative complications
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Protection of trial subjects |
Study approved by Ethics committee. Study participants protected from Swedish law.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Sweden: 59
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Worldwide total number of subjects |
59
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EEA total number of subjects |
59
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
23
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From 65 to 84 years |
36
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85 years and over |
0
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Recruitment
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Recruitment details |
After oral and written informed consent had been obtained adult patients scheduled for elective transthoracic oesophageal resection because of malignancy at University Hospital Linkoping or University Hospital Orebro were randomised. | |||||||||
Pre-assignment
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Screening details |
Adult patients scheduled for elective transthoracic oesophageal resection because of malignancy were randomised. Exclusion criteria were emergency procedures, planned colonic interposition, ASA class 4 or 5 patients or those for whom more extensive cardiac monitoring was planned, significant aortic or mitral valve insuffiency | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | |||||||||
Arm description |
Goal-directed fluid therapy guided by pulse contour analysis | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
dobutamine
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Investigational medicinal product code |
C01CA07
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Initially 2,5µg/kg/min with the purpose to achieve cardiac index > 2,5 l/min/m2. Restrited by signs of cardiac ischemia or heart rate over 90 beats/min
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Investigational medicinal product name |
Volulyte
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Investigational medicinal product code |
23245
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
3 ml/kg (max 250 ml) as a bolus during 5 minutes. Wait for 5 minutes and evaluate change in heart stroke volume. If increased by more than 10%, repeat another bolus until no further increase over 10% in stroke volume or DO2i over 600 ml/min/m2.
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Arm title
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Control group | |||||||||
Arm description |
the responsible anaesthetist deter- mined the fluid administration rate and use of vasocon- strictors and inotropes. Stroke volume and Cardiac Index were not measured. | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Goal-directed fluid therapy guided by pulse contour analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control group
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Reporting group description |
the responsible anaesthetist deter- mined the fluid administration rate and use of vasocon- strictors and inotropes. Stroke volume and Cardiac Index were not measured. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Goal-directed fluid therapy guided by pulse contour analysis | ||
Reporting group title |
Control group
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Reporting group description |
the responsible anaesthetist deter- mined the fluid administration rate and use of vasocon- strictors and inotropes. Stroke volume and Cardiac Index were not measured. |
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End point title |
Postop complication after 5 days | |||||||||
End point description |
Postoperative days 0 to 5
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End point type |
Primary
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End point timeframe |
Days
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Statistical analysis title |
postop compl 5 days | |||||||||
Comparison groups |
Intervention v Control group
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Number of subjects included in analysis |
59
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.1 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Postop complication after 30 days | |||||||||
End point description |
Accumulated number of complication after surgery up to 30 days postoperatively
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End point type |
Primary
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End point timeframe |
Postop 0 to 30 days
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Statistical analysis title |
Postop compl 30 days | |||||||||
Comparison groups |
Intervention v Control group
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Number of subjects included in analysis |
59
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.1 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
o-30 days postoperatively
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
Prespecified list of | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
korr 12121
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Reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Goal-directed fluid therapy guided by pulse contour analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control group
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Reporting group description |
the responsible anaesthetist deter- mined the fluid administration rate and use of vasocon- strictors and inotropes. Stroke volume and Cardiac Index were not measured. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30431499 |