Fluid OverloadPhase 4CCNCT00517127
Crystalloids Versus Colloids During Surgery
A Phase 4 study testing Lactated Ringer's Solution and Hydroxyethylstarch 6% 130/0.4 in people with Fluid Overload and Postoperative Complications, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Overload, Postoperative Complications
- What is being tested?
- Lactated Ringer's Solution and Hydroxyethylstarch 6% 130/0.4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,109 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2006to 31 Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After written informed consent patients undergoing elective open colon surgery, or open hysterectomy or myomectomy, or spine surgery or hip replacement will be included in the study.
Who cannot join
- Patients having severe cardiac or renal insufficiency
- Patients with severe coronary artery disease
- Patients with insulin-dependent diabetes mellitus
- Patients with severe COPD
- Patients with symptoms of infections or sepsis
- Patients with allergy to hydroxyethylstarch.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management
The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device.
Read the detailed description
For a long time there is a raging debate whether crystalloid solutions or colloid solutions are better suited for fluid therapy. Early proponents both for crystalloids [Shires 1961] and colloids [Shoemaker 1979] deserve credit for elucidating important facts about volume replacement therapy - without answering the primary question. Elaborate reviews comparing crystalloid and colloid therapy for critically ill patients have been performed in the late nineties and updated recently [Roberts 2004]. However, it has been suggested that both questions and answers of reviews leave us none but wiser [Webb 1999]. Although a plethora of studies comparing crystalloid vs. colloid therapy in the last decades have been published, volume replacement therapy is still considered to be based on dogma and personal beliefs [Boldt 2003].
Goal-directed intraoperative fluid therapy monitored by Esophageal Doppler identifies volume-responders, thereby decreasing length of stay in hospital in orthopedic [Sinclair 1997], cardiac [Mythen 1995], and abdominal surgery patients [Gan 2002, Wakeling 2005, Noblett 2006]. However, all these studies have been performed with a colloid to be the substance applied. Thus, it has been questioned whether monitoring with the Esophageal Doppler monitor, or the application of additional colloid improved outcome [Horowitz, Kumar 2003].
Consequently, the researchers will use Esophageal Doppler Monitoring for intraoperative goal-directed fluid therapy to compare the effects of crystalloid vs. colloid therapy on various organ systems, assessing combined perioperative morbidity [Bennett-Guerrero 1999] .
- Conditions
- Fluid Overload, Postoperative Complications
- Being tested
- Lactated Ringer's Solution, Hydroxyethylstarch 6% 130/0.4
- Keywords
- Intraoperative care, Ringer's lactate, Voluven, Cardiovascular diagnostic technique, Doppler effect
- Medical subject headings
- Edema, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer's SolutionDrug
Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.
Hydroxyethylstarch 6% 130/0.4Drug
Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered. Receives: Drug: Lactated Ringer's Solution |
| 2 | Active comparator | Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered. Receives: Drug: Hydroxyethylstarch 6% 130/0.4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined perioperative morbidity
Measured: 30 days after surgery
Secondary outcomes (1)
Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startSep 2006
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Principal investigator, Barbara Kabon, Medical University of Vienna
- Investigators
- Edith Fleischmann, M.D., Ph.D., Principal investigator, Department of Anesthesiology, University of Vienna Medical School, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517127
- Sponsor's protocol ID
- 431/2005
- Acronym
- CC
- Status last verified
- Jan 2018
- First submitted
- 15 Aug 2007
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
SHIRES T, WILLIAMS J, BROWN F. Acute change in extracellular fluids associated with major surgical procedures. Ann Surg. 1961 Nov;154(5):803-10. doi: 10.1097/00000658-196111000-00005. No abstract available.
PubMed 13912109Shoemaker WC, Hauser CJ. Critique of crystalloid versus colloid therapy in shock and shock lung. Crit Care Med. 1979 Mar;7(3):117-24. doi: 10.1097/00003246-197903000-00007. No abstract available.
PubMed 436427Roberts I, Alderson P, Bunn F, Chinnock P, Ker K, Schierhout G. Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000567. doi: 10.1002/14651858.CD000567.pub2.
PubMed 15495001Webb AR. Crystalloid or colloid for resuscitation. Are we any the wiser? Crit Care. 1999;3(3):R25-R28. doi: 10.1186/cc346. No abstract available.
PubMed 11094479Boldt J. New light on intravascular volume replacement regimens: what did we learn from the past three years? Anesth Analg. 2003 Dec;97(6):1595-1604. doi: 10.1213/01.ANE.0000089961.15975.78.
PubMed 14633526Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.
PubMed 9361539Mythen MG, Webb AR. Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg. 1995 Apr;130(4):423-9. doi: 10.1001/archsurg.1995.01430040085019.
PubMed 7535996Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
PubMed 12357146Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
PubMed 16155038Noblett SE, Snowden CP, Shenton BK, Horgan AF. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection. Br J Surg. 2006 Sep;93(9):1069-76. doi: 10.1002/bjs.5454.
PubMed 16888706Horowitz PE, Kumar A. It's the colloid, not the esophageal Doppler monitor. Anesthesiology. 2003 Jul;99(1):238-9; author reply 239. doi: 10.1097/00000542-200307000-00045. No abstract available.
PubMed 12826872Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
PubMed 10439777Obradovic M, Luf F, Reiterer C, Schoppmann S, Kurz A, Fleischmann E, Kabon B. The effect of goal-directed crystalloid versus colloid administration on postoperative spirometry parameters: a substudy of a randomized controlled clinical trial. Perioper Med (Lond). 2024 Apr 15;13(1):28. doi: 10.1186/s13741-024-00381-z.
PubMed 38622671Obradovic M, Kurz A, Kabon B, Roth G, Kimberger O, Zotti O, Bayoumi A, Reiterer C, Stift A, Fleischmann E. The effect of intraoperative goal-directed crystalloid versus colloid administration on perioperative inflammatory markers - a substudy of a randomized controlled trial. BMC Anesthesiol. 2020 Aug 21;20(1):210. doi: 10.1186/s12871-020-01126-3.
PubMed 32825817Reiterer C, Kabon B, Zotti O, Obradovic M, Kurz A, Fleischmann E. Effect of goal-directed crystalloid- versus colloid-based fluid strategy on tissue oxygen tension: a randomised controlled trial. Br J Anaesth. 2019 Dec;123(6):768-776. doi: 10.1016/j.bja.2019.08.027. Epub 2019 Oct 15.
PubMed 31627889
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management
- ClinicalTrials.gov ID
- NCT00517127
- Acronym / sponsor ID
- CC / 431/2005
- Conditions
- Fluid Overload, Postoperative Complications
- Keywords
- Intraoperative care, Ringer's lactate, Voluven, Cardiovascular diagnostic technique, Doppler effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,109 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- Sep 2006
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device.
Detailed description
For a long time there is a raging debate whether crystalloid solutions or colloid solutions are better suited for fluid therapy. Early proponents both for crystalloids [Shires 1961] and colloids [Shoemaker 1979] deserve credit for elucidating important facts about volume replacement therapy - without answering the primary question. Elaborate reviews comparing crystalloid and colloid therapy for critically ill patients have been performed in the late nineties and updated recently [Roberts 2004]. However, it has been suggested that both questions and answers of reviews leave us none but wiser [Webb 1999]. Although a plethora of studies comparing crystalloid vs. colloid therapy in the last decades have been published, volume replacement therapy is still considered to be based on dogma and personal beliefs [Boldt 2003].
Goal-directed intraoperative fluid therapy monitored by Esophageal Doppler identifies volume-responders, thereby decreasing length of stay in hospital in orthopedic [Sinclair 1997], cardiac [Mythen 1995], and abdominal surgery patients [Gan 2002, Wakeling 2005, Noblett 2006]. However, all these studies have been performed with a colloid to be the substance applied. Thus, it has been questioned whether monitoring with the Esophageal Doppler monitor, or the application of additional colloid improved outcome [Horowitz, Kumar 2003].
Consequently, the researchers will use Esophageal Doppler Monitoring for intraoperative goal-directed fluid therapy to compare the effects of crystalloid vs. colloid therapy on various organ systems, assessing combined perioperative morbidity [Bennett-Guerrero 1999] .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Lactated Ringer's SolutionArm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered. |
| 2 | Active comparator | Drug: Hydroxyethylstarch 6% 130/0.4Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- After written informed consent patients undergoing elective open colon surgery, or open hysterectomy or myomectomy, or spine surgery or hip replacement will be included in the study.
Key exclusion criteria (6 listed)
- Patients having severe cardiac or renal insufficiency
- Patients with severe coronary artery disease
- Patients with insulin-dependent diabetes mellitus
- Patients with severe COPD
- Patients with symptoms of infections or sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactated Ringer's SolutionArm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered. | Drug | 1 |
| Hydroxyethylstarch 6% 130/0.4Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered. | Drug | 2 |
Primary outcome
combined perioperative morbidity
Time frame: 30 days after surgery
1 secondary outcome
Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Background: PubMed 13912109SHIRES T, WILLIAMS J, BROWN F. Acute change in extracellular fluids associated with major surgical procedures. Ann Surg. 1961 Nov;154(5):803-10. doi: 10.1097/00000658-196111000-00005. No abstract available.
- Background: PubMed 436427Shoemaker WC, Hauser CJ. Critique of crystalloid versus colloid therapy in shock and shock lung. Crit Care Med. 1979 Mar;7(3):117-24. doi: 10.1097/00003246-197903000-00007. No abstract available.
- Background: PubMed 15495001Roberts I, Alderson P, Bunn F, Chinnock P, Ker K, Schierhout G. Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000567. doi: 10.1002/14651858.CD000567.pub2.
- Background: PubMed 11094479Webb AR. Crystalloid or colloid for resuscitation. Are we any the wiser? Crit Care. 1999;3(3):R25-R28. doi: 10.1186/cc346. No abstract available.
- Background: PubMed 14633526Boldt J. New light on intravascular volume replacement regimens: what did we learn from the past three years? Anesth Analg. 2003 Dec;97(6):1595-1604. doi: 10.1213/01.ANE.0000089961.15975.78.
- Background: PubMed 9361539Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.
- Background: PubMed 7535996Mythen MG, Webb AR. Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg. 1995 Apr;130(4):423-9. doi: 10.1001/archsurg.1995.01430040085019.
- Background: PubMed 12357146Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
- Background: PubMed 16155038Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
- Background: PubMed 16888706Noblett SE, Snowden CP, Shenton BK, Horgan AF. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection. Br J Surg. 2006 Sep;93(9):1069-76. doi: 10.1002/bjs.5454.
- Background: PubMed 12826872Horowitz PE, Kumar A. It's the colloid, not the esophageal Doppler monitor. Anesthesiology. 2003 Jul;99(1):238-9; author reply 239. doi: 10.1097/00000542-200307000-00045. No abstract available.
- Background: PubMed 10439777Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Fleischmann, M.D., Ph.D. principal investigator
Department of Anesthesiology, University of Vienna Medical School, Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactated Ringer's Solution and Hydroxyethylstarch 6% 130/0.4 in people with Fluid Overload and Postoperative Complications, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combined perioperative morbidity (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00517127, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018; AzTrials last refreshed its copy on 27 Oct 2026.