An interventional study of Fluid management and Norepinephrine in Optimal Tissue Perfusion, sponsored by Szeged University. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Szeged University · Not applicable, Interventional, and Treatment
Maintaining satisfactory tissue perfusion is an essential of success during reconstructive free flap surgery following malign oral cavity tumours. Intra- and postoperative goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary) might be superior to conventional, central venous and arterial pressure monitoring in terms of morbidity, complications, optimal fluid balance and days spent in hospital. However, there is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on microcirculation of free flaps implanted in the oral cavity during the post-operative period. The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring based, goal-directed fluid therapy on microcirculation of forearm flaps during the perioperative period.
Szeged University is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
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Other: Fluid management · Drug: Norepinephrine · Drug: Dobutamine
Other: Fluid management · Drug: Norepinephrine · Drug: Dobutamine
Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid. If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.
Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg. Mean arterial pressure must be maintained above 65 mmHg. Norepinephrine is titrated accordingly.
Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2. Cardiac index must be maintained above 2.5 L/min/m2. Dobutamine is titrated accordingly.
Changes of Pulse pressure variation during the operation and the post-operative 24 hours
Time frame: 24 hours
Assesment of free falp microcirculation by laser dopler flowmetry method.
Time frame: 24 hours
Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.
Time frame: 24 hours
Changes of Cardiac Index during the operation and the post-operative 24 hours.
Time frame: 24 hours
Mean arterial pressure during the operation and the post-operative 24 hours.
Time frame: 24 hours
Length of Intensive Care Unit stay
Time frame: 24 hours
Number of surgical or non-surgical complications.
Time frame: 24 hours
Length of Hospital stay
Time frame: 10 days
Ran from Apr 2014 to primary completion in Feb 2017, 34 months.
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Norepinephrine · Dobutamine
Szeged University