Postoperative ComplicationsNCT02470221
Goal-directed Intraoperative Fluid Therapy in High-risk Surgery
An observational study of Postoperative Complications and Fluid Overload, run by Huang YuGuang.
Trial summary
This study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Complications, Fluid Overload
- What is being tested?
- Applying goal-directed fluid therapy by continuous hemodynamic monitoring system and Conventional fluid therapy
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Jul 2018
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent either laparotomy of gynecological malignancies or orthopedic surgery
Who may be able to join
- Receiving elective laparotomy of gynecological malignancies (LGM): including cytoreductive surgery of ovarian cancer, radical hysterectomy and staging surgery of endometrial cancer ;
- Major elective orthopedic surgery (OS): including spinal surgery, revision surgery of hip joints ;
- Age ≥18 years, American Society of Anesthesiologists physical status I ～IV;
- No arrhythmia;
- Receiving general anesthesia;
- Requiring monitoring of direct blood pressure due to the comorbidities of patients and the nature of surgical procedures.
Who cannot join
- Emergent surgery;
- Patients with aortic regurgitation;
- Patients with aortic stenosis, peripheral arterial diseases or other diseases contradicting to arterial canalizations;
- Patients with mental disorders or low intelligence quotient; patients who cannot cooperate or refuse to sign the consent.
About this study
Official title: Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic Surgery
This study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost.
This is an observational study followed cohort study design, due to the two therapies were not randomized assigned to the two cohorts. The details are described as follow.
Read the detailed description
The study will be conducted in patients undergoing either elective laparotomy of gynecological malignancies or elective major orthopaedic surgery under prone position in Peking Union Medical College Hospital. The study included two stages.
In the first stage, one cohort of 300 participants with conventional fluid therapy will be involved, in which 150 patients will be selected with laparotomy of gynecological malignancies and150 patients will be selected with orthopedic surgery. All the participants in this stage will follow conventional fluid therapy to direct the amount of intraoperative fluid. Specifically, the fluid will be administered based on the principle crystalloid solution (colloid solution =2-3:1). The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. It is a standard procedure in Peking Union Medical College Hospital. Then, the incidence of postoperative complications of each group will be recorded. In addition, sample size will be estimated based on above study's results (estimated 100 participants).
In the second stage, goal-directed therapy will be applied to another cohort of 300 participants, in which 150 patients undergoing laparotomy of gynecological malignancies and 150 patients undergoing orthopedic surgery. Specifically, the fluid will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. The incidence of postoperative complications of each group will be recorded.
- Conditions
- Postoperative Complications, Fluid Overload
- Being tested
- Applying goal-directed fluid therapy by continuous hemodynamic monitoring system, Conventional fluid therapy
- Keywords
- goal-directed fluid therapy, intraoperative hemodynamics, postoperative complications
- Medical subject headings
- Postoperative Complications, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applying goal-directed fluid therapy by continuous hemodynamic monitoring systemOther
Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.
Conventional fluid therapyOther
Applying conventional fluid therapy according to Peking Union Medical College Hospital standard.
| Study group | Role | What they receive |
|---|---|---|
| Goal-directed fluid therapy | The fluid in group Goal-directed fluid therapy will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. Receives: Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system | |
| Conventional fluid therapy | The fluid in group Conventional fluid therapy will be administered based on the principle crystalloid solution: colloid solution =2-3:1. The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. Receives: Other: Conventional fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
the incidence of complications related to surgeries 30 days postoperatively. The complications include pneumonia, pulmonary embolism, cardiovascular events (myocardial infarction, heart failure), wound infection, gastrointestinal bleeding,nausea and vomitting，postoperative hemorrhage, ileus, deep venous thrombosis, cerebral infarction, cerebral embolism, cerebral hemorrhage, renal insufficiency and failure. Those complications are defined strictly to the reference published in 2009 New England Journal of Medicine （N Engl J Med. 2009 Oct 1;361:1368-75）
Measured: 30 days after the surgery
Secondary outcomes (2)
hospital length of stay
the length of stay in hospital，from the hospitalized date to the leave date
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
hospital expenses
total cost in hospital
Measured: 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study start1 Mar 2016
- Primary completion10 Feb 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huang YuGuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huang YuGuang, Peking Union Medical College Hospital
- Investigators
- Yuguang Huang, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470221
- Sponsor's protocol ID
- anesthesiologyPUMCH001
- Status last verified
- May 2019
- First submitted
- 28 May 2015
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.
PubMed 21624138Kuper M, Gold SJ, Callow C, Quraishi T, King S, Mulreany A, Bianchi M, Conway DH. Intraoperative fluid management guided by oesophageal Doppler monitoring. BMJ. 2011 May 24;342:d3016. doi: 10.1136/bmj.d3016.
PubMed 21610051Wang P, Wang HW, Zhong TD. Effect of stroke volume variability- guided intraoperative fluid restriction on gastrointestinal functional recovery. Hepatogastroenterology. 2012 Nov-Dec;59(120):2457-60. doi: 10.5754/hge12283.
PubMed 22626878Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22.
PubMed 23264068Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.
PubMed 17925428Che L, Zhang XH, Li X, Zhang YL, Xu L, Huang YG. Outcome impact of individualized fluid management during spine surgery: a before-after prospective comparison study. BMC Anesthesiol. 2020 Jul 22;20(1):181. doi: 10.1186/s12871-020-01092-w.
PubMed 32698766
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02470221
- Acronym / sponsor ID
- anesthesiologyPUMCH001
- Conditions
- Postoperative Complications, Fluid Overload
- Keywords
- goal-directed fluid therapy, intraoperative hemodynamics, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Huang YuGuangUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 12 Jun 2015 (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.
This study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost.
This is an observational study followed cohort study design, due to the two therapies were not randomized assigned to the two cohorts. The details are described as follow.
Detailed description
The study will be conducted in patients undergoing either elective laparotomy of gynecological malignancies or elective major orthopaedic surgery under prone position in Peking Union Medical College Hospital. The study included two stages.
In the first stage, one cohort of 300 participants with conventional fluid therapy will be involved, in which 150 patients will be selected with laparotomy of gynecological malignancies and150 patients will be selected with orthopedic surgery. All the participants in this stage will follow conventional fluid therapy to direct the amount of intraoperative fluid. Specifically, the fluid will be administered based on the principle crystalloid solution (colloid solution =2-3:1). The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. It is a standard procedure in Peking Union Medical College Hospital. Then, the incidence of postoperative complications of each group will be recorded. In addition, sample size will be estimated based on above study's results (estimated 100 participants).
In the second stage, goal-directed therapy will be applied to another cohort of 300 participants, in which 150 patients undergoing laparotomy of gynecological malignancies and 150 patients undergoing orthopedic surgery. Specifically, the fluid will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. The incidence of postoperative complications of each group will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-directed fluid therapy | – | Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring systemThe fluid in group Goal-directed fluid therapy will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. |
| Conventional fluid therapy | – | Other: Conventional fluid therapyThe fluid in group Conventional fluid therapy will be administered based on the principle crystalloid solution: colloid solution =2-3:1. The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent either laparotomy of gynecological malignancies or orthopedic surgery
Key inclusion criteria (6 listed)
- Receiving elective laparotomy of gynecological malignancies (LGM): including cytoreductive surgery of ovarian cancer, radical hysterectomy and staging surgery of endometrial cancer ;
- Major elective orthopedic surgery (OS): including spinal surgery, revision surgery of hip joints ;
- Age ≥18 years, American Society of Anesthesiologists physical status I ～IV;
- No arrhythmia;
- Receiving general anesthesia;
Key exclusion criteria (4 listed)
- Emergent surgery;
- Patients with aortic regurgitation;
- Patients with aortic stenosis, peripheral arterial diseases or other diseases contradicting to arterial canalizations;
- Patients with mental disorders or low intelligence quotient; patients who cannot cooperate or refuse to sign the consent.
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 |
|---|---|---|
| Applying goal-directed fluid therapy by continuous hemodynamic monitoring systemApplying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy. | Other | Goal-directed fluid therapy |
| Conventional fluid therapyApplying conventional fluid therapy according to Peking Union Medical College Hospital standard. | Other | Conventional fluid therapy |
Primary outcome
postoperative complications
Time frame: 30 days after the surgery
the incidence of complications related to surgeries 30 days postoperatively. The complications include pneumonia, pulmonary embolism, cardiovascular events (myocardial infarction, heart failure), wound infection, gastrointestinal bleeding,nausea and vomitting，postoperative hemorrhage, ileus, deep venous thrombosis, cerebral infarction, cerebral embolism, cerebral hemorrhage, renal insufficiency and failure. Those complications are defined strictly to the reference published in 2009 New England Journal of Medicine （N Engl J Med. 2009 Oct 1;361:1368-75）
2 secondary outcomes
hospital length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
hospital expenses
Time frame: 30 days after the 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 31 May 2019.
- Background: PubMed 21624138Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.
- Background: PubMed 21610051Kuper M, Gold SJ, Callow C, Quraishi T, King S, Mulreany A, Bianchi M, Conway DH. Intraoperative fluid management guided by oesophageal Doppler monitoring. BMJ. 2011 May 24;342:d3016. doi: 10.1136/bmj.d3016.
- Background: PubMed 22626878Wang P, Wang HW, Zhong TD. Effect of stroke volume variability- guided intraoperative fluid restriction on gastrointestinal functional recovery. Hepatogastroenterology. 2012 Nov-Dec;59(120):2457-60. doi: 10.5754/hge12283.
- Background: PubMed 23264068Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22.
- Background: PubMed 17925428Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.
- Derived from this study: PubMed 32698766Che L, Zhang XH, Li X, Zhang YL, Xu L, Huang YG. Outcome impact of individualized fluid management during spine surgery: a before-after prospective comparison study. BMC Anesthesiol. 2020 Jul 22;20(1):181. doi: 10.1186/s12871-020-01092-w.
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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.
Yuguang Huang, MD study chair
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Fluid Overload, run by Huang YuGuang.
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 6 inclusion and 4 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 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
postoperative complications (time frame: 30 days after the 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 NCT02470221, which also lists 6 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 31 May 2019.