Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-28

Study Completion Date

2018-09-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Optimal Tissue Perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Crystalloid group

Group Type ACTIVE_COMPARATOR

Fluid management

Intervention Type OTHER

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Colloid group

Group Type ACTIVE_COMPARATOR

Fluid management

Intervention Type OTHER

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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Fluid management

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.

Intervention Type OTHER

Norepinephrine

Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg. Mean arterial pressure must be maintained above 65 mmHg. Norepinephrine is titrated accordingly.

Intervention Type DRUG

Dobutamine

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.

Intervention Type DRUG