Renal Function Test, Urine Output, Lactate LevelNCT03780686
Dopamine and Norepinephrine Infusion With Restricted Hydration
A study testing Norepinephrine, dopamine in people with Renal Function Test, Urine Output, Lactate Level, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Function Test, Urine Output, Lactate Level
- What is being tested?
- Norepinephrine, dopamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Apr 2017to 15 Dec 2018
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with American Society of Anesthesiologists (ASA) physical status I or II
- Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy were contained in the study.
Who cannot join
- Patients with coagulopathies,
- Hepatic dysfunction (prothrombin ratio <50%),
- Renal dysfunction,
- Congestive heart failure (New York Heart Association scores ≥3),
- Contraindications for epidural analgesia (e.g. patient refusal, local infection or coagulopathy), and peripheral vascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries
This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.
Read the detailed description
One hundred and twenty patients were randomly assigned into three groups (dopamine norepinephrine group, restrictive hydration group and liberal hydration group) undergoing open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was introduced according to maintenance, deficit for the first 3 hours (hours fasting x body weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).
The outcome to be assessed was serial measurements of serum lactate intraoperatively and immediate postoperatively as an index of tissue perfusion, in addition to blood pressure, heart rate and oxygen saturation.
- Being tested
- Norepinephrine, dopamine
- Keywords
- Restrictive hydration,, Dopamine,, Norepinephrine,, Serum lactate,, Standard hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine, dopamineDrug
drugs to decrease bleeding
| Study group | Role | What they receive |
|---|---|---|
| Dopamine and norepinephrine infusion | Active comparator | Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid Receives: Drug: Norepinephrine, dopamine |
| Norepinephrine | Active comparator | Infusion norepinephrine (3mcg/kg/h) with restricted fluid. Receives: Drug: Norepinephrine, dopamine |
| Standard fluid management | No intervention | Standard fluid managements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum lactate level
Serum lactate level in mmol/l
Measured: Before induction of anesthesia and up to 12 hours after.
Changes in renal function test
Measuring creatinine level
Measured: Before induction of anesthesia and up to 12 hours after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start9 Apr 2017
- Primary completion20 Nov 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Function Test, Urine Output, Lactate LevelStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Anis Metry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780686
- Sponsor's protocol ID
- ASUH3206/17
- Status last verified
- Dec 2018
- First submitted
- 16 Dec 2018
- Last updated
- 20 Dec 2018
- 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 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT03780686
- Acronym / sponsor ID
- ASUH3206/17
- Keywords
- Restrictive hydration,, Dopamine,, Norepinephrine,, Serum lactate,, Standard hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Apr 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 19 Dec 2018 (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.
This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.
Detailed description
One hundred and twenty patients were randomly assigned into three groups (dopamine norepinephrine group, restrictive hydration group and liberal hydration group) undergoing open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was introduced according to maintenance, deficit for the first 3 hours (hours fasting x body weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).
The outcome to be assessed was serial measurements of serum lactate intraoperatively and immediate postoperatively as an index of tissue perfusion, in addition to blood pressure, heart rate and oxygen saturation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dopamine and norepinephrine infusion | Active comparator | Drug: Norepinephrine, dopamineInfusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid |
| Norepinephrine | Active comparator | Drug: Norepinephrine, dopamineInfusion norepinephrine (3mcg/kg/h) with restricted fluid. |
| Standard fluid management | No intervention | –Standard fluid managements. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with American Society of Anesthesiologists (ASA) physical status I or II
- Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy were contained in the study.
Key exclusion criteria (5 listed)
- Patients with coagulopathies,
- Hepatic dysfunction (prothrombin ratio <50%),
- Renal dysfunction,
- Congestive heart failure (New York Heart Association scores ≥3),
- Contraindications for epidural analgesia (e.g. patient refusal, local infection or coagulopathy), and peripheral vascular disease.
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 |
|---|---|---|
| Norepinephrine, dopaminedrugs to decrease bleeding | Drug | Dopamine and norepinephrine infusion, Norepinephrine |
Primary outcome
Changes in serum lactate level
Time frame: Before induction of anesthesia and up to 12 hours after.
Serum lactate level in mmol/l
Changes in renal function test
Time frame: Before induction of anesthesia and up to 12 hours after.
Measuring creatinine level
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 20 Dec 2018.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine, dopamine in people with Renal Function Test, Urine Output, Lactate Level, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 5 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 20 Dec 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 Egypt. 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.
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?
Changes in serum lactate level (time frame: Before induction of anesthesia and up to 12 hours after.). The study lists 2 primary outcomes in all. 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 20 Dec 2018.