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Dopamine and Norepinephrine Infusion With Restricted Hydration

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03780686
Enrollment
120
Registered
2018-12-19
Start date
2017-04-09
Completion date
2018-12-15
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Function Test, Urine Output, Lactate Level

Keywords

Restrictive hydration,, Dopamine,, Norepinephrine,, Serum lactate,, Standard hydration

Brief 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.

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.

Interventions

DRUGNorepinephrine, dopamine

drugs to decrease bleeding

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in serum lactate levelBefore induction of anesthesia and up to 12 hours after.Serum lactate level in mmol/l
Changes in renal function testBefore induction of anesthesia and up to 12 hours after.Measuring creatinine level

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026