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Fluid Challenge and Plasma Volume, During Surgery

ConditionsColorectal CancerUrologic CancerGynecologic CancerColorectal DisordersBenign Neoplasm
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJoachim Zdolsek

About this trial

A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written consent to participate in the study

For women: relevant contraceptive, menopausal or a negative pregnancy test.

ASA category I to III

Laparoscopic abdominal surgery, with a duration of at least 90 minutes.

Disqualifiers

Patients with known cardiac failure

<18 or >85 years

known allergy to albumin

extracellular hyperhydration or hypervolemia

Trial design

Design model

Parallel

Treatments tested in this trial

  • acetated Ringers

    Drug

    After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first fluid bolus is infused. Circulatory and volume effects are studied. If cardiac output increase a second bolus is infused and studied.

  • albumin 5%

    Drug

    After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.

  • albumin 20%

    Drug

    After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: acetated RingersExperimental treatment 1 intervention
Group B: albumin 5%Experimental treatment 1 intervention
Group C: albumin 20%Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Plasma volume expansion after a fluid bolus

Plasma volume using hemoglobin as an indicator of dilution

Time frame
60 minutes after an intravenous fluid bolus

Secondary outcomes

1

Fluid Balance

Calculations of fluid balance

Time frame
18 to 24 hours
2

Stroke Volume

Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))

Time frame
60 minutes after an intravenous fluid bolus
3

Arterial Blood Pressure

Mean Arterial Pressure, measured with an arterial line.

Time frame
60 minutes after an intravenous fluid bolus
4

Heart Rate

Heart rate, measured with ECG and pulseoximeter.

Time frame
60 minutes after an intravenous fluid bolus

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joachim Zdolsek

Lead sponsor

University Hospital, Linkoeping

Sponsor institution

Source ClinicalTrials.gov
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