TerminatedNot Applicable

Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery

Stopped: recrutment difficulties

Switzerland20 participantsStarted 2010-04

Plain-language summary

This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults \> 18 years * Severe sepsis\* as defined by the ACCCP/SCCM consensus conference * Need for emergent interventional procedure under general anesthesia with an expected duration \> 120 min (in and out patients). Exclusion Criteria: * Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC * Neurotrauma (Glasgow Coma Score \< 12) and/ or medullar trauma * Known pregnancy or diagnosed by US or Ct-scan (\> 14 weeks) * Sustained cardiac arrhythmia (see Logbook P8) * Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8) * Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8) * Burn injury \> 10% * Needed emergency thoracotomy or ABC resuscitation protocol * Pre-existing severe liver dysfunction(Child-Pugh class C) * Do-not-resuscitate order, died within 48h of admission

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Delta lactate

Timeframe: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours.

Trial details

NCT IDNCT01654003

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Severe Sepsis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.