Dopamine and Norepinephrine Infusion With Restricted Hydration

NCT03780686 — Not applicable, Completed, 120 participants, Ain Shams University

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The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries

Registry	NCT03780686
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, diagnostic
Enrollment	120 (Actual)
Sponsor	Ain Shams University (Other)
Conditions	Renal Function Test, Urine Output, Lactate Level
Interventions	Norepinephrine, dopamine (Drug)
Dates	start 2017-04-09, primary completion 2018-11-20, completion 2018-12-15, first posted 2018-12-19, last updated 2018-12-20
Locations	1 site in Egypt

-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 infusion only and standard hydration during open abdominal surgeries.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Dopamine and norepinephrine infusion	Active comparator	Drug: Norepinephrine, dopamine	Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid
Norepinephrine	Active comparator	Drug: Norepinephrine, dopamine	Infusion norepinephrine (3mcg/kg/h) with restricted fluid.
Standard fluid management	No intervention		Standard fluid managements.

Norepinephrine, dopamine (Drug): drugs to decrease bleeding

+Outcome measures

Primary outcomes

Changes in serum lactate level [Before induction of anesthesia and up to 12 hours after.]: Serum lactate level in mmol/l
Changes in renal function test [Before induction of anesthesia and up to 12 hours after.]: Measuring creatinine level

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
Ain Shams University	Cairo	Egypt