Organ Failure, MultipleNCT03933930
Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
A study testing Lactate-directed therapy and Goal-directed therapy in people with Organ Failure, Multiple, run by Taipei Medical University WanFang Hospital.
Trial summary
Hyperthermic intraperitoneal chemotherapy is a major surgery for tumor peritoneal metastasis. For anesthesiologist, the intra-operative fluid control is always a big challenge. We try to compare the prognosis of lactate-directed and goal-directed therapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Organ Failure, Multiple
- What is being tested?
- Lactate-directed therapy and Goal-directed therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2019to 15 May 2021
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving hyperthermic intraperitoneal chemotherapy
Who cannot join
- Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients
About this study
Hyperthermic intraperitoneal chemotherapy is a major surgery for tumor peritoneal metastasis. For anesthesiologist, the intra-operative fluid control is always a big challenge. We try to compare the prognosis of lactate-directed and goal-directed therapy. We expect to confirm the better prognosis of lactate-directed therapy.
- Conditions
- Organ Failure, Multiple
- Being tested
- Lactate-directed therapy, Goal-directed therapy
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate-directed therapyOther
If the lactate level elevates, we transfuse pRBC to increase Hct>30%. If Hct >30%, dopamine infusion starts.
Goal-directed therapyOther
If SVV>15%, transfuse lactate ringer/normal saline alternatively to keep SVV<15%.
| Study group | Role | What they receive |
|---|---|---|
| Lactate-directed therapy | Experimental | Not described Receives: Other: Lactate-directed therapy; Other: Goal-directed therapy |
| Goal-directed therapy | Experimental | Not described Receives: Other: Goal-directed therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary complication
X-ray findings of airspace or interstitial opacity, lobar consolidation, or pleural effusions; severe respiratory failure requiring respiratory support
Measured: 1 week
Secondary outcomes (1)
Renal complication
oliguria with urine output<0.5 ml/kg/h for more than 4 h, creatinine increase>30 % of preoperative values, dialysis
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start6 May 2019 (estimated)
- Primary completion15 May 2021 (estimated)
- Study completion15 May 2021 (estimated)
Why it stopped: No patient wants to be recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Failure, MultipleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, anchihhsu, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933930
- Sponsor's protocol ID
- N201803039
- Status last verified
- May 2020
- First submitted
- 12 Apr 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
- ClinicalTrials.gov ID
- NCT03933930
- Acronym / sponsor ID
- N201803039
- Conditions
- Organ Failure, Multiple
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient wants to be recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 6 May 2019 (estimated)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 1 May 2019 (actual)
- 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.
Hyperthermic intraperitoneal chemotherapy is a major surgery for tumor peritoneal metastasis. For anesthesiologist, the intra-operative fluid control is always a big challenge. We try to compare the prognosis of lactate-directed and goal-directed therapy. We expect to confirm the better prognosis of lactate-directed therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactate-directed therapy | Experimental | Other: Lactate-directed therapy, Other: Goal-directed therapy |
| Goal-directed therapy | Experimental | Other: Goal-directed therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving hyperthermic intraperitoneal chemotherapy
Key exclusion criteria (1 listed)
- Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients
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 |
|---|---|---|
| Lactate-directed therapyIf the lactate level elevates, we transfuse pRBC to increase Hct>30%. If Hct >30%, dopamine infusion starts. | Other | Lactate-directed therapy |
| Goal-directed therapyIf SVV>15%, transfuse lactate ringer/normal saline alternatively to keep SVV<15%. | Other | Goal-directed therapy, Lactate-directed therapy |
Primary outcome
pulmonary complication
Time frame: 1 week
X-ray findings of airspace or interstitial opacity, lobar consolidation, or pleural effusions; severe respiratory failure requiring respiratory support
1 secondary outcome
Renal complication
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lactate-directed therapy and Goal-directed therapy in people with Organ Failure, Multiple, run by Taipei Medical University WanFang Hospital.
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 1 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: withdrawn, as of the sponsor's last update on 4 Jun 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
pulmonary complication (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.