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Early Goal-Directed Therapy With and Without Intermittent Superior Vena Cava Oxygen Saturation Monitoring in Pediatric Septic Shock: A Randomized Controlled Trial

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An Erratum to this article was published on 01 April 2022

This article has been updated

Abstract

Objective

To compare early goal-directed therapy (EGDT) ‘with’ and ‘without’ intermittent superior vena cava oxygen saturation (ScvO2) monitoring in pediatric septic shock.

Design

Open label randomized controlled trial.

Setting

Pediatric intensive care unit in a tertiary care center.

Participants

Children aged 1 month to 12 year with septic shock.

Intervention

Patients not responding to fluid resuscitation (up to 40 mL/kg) were randomized to EGDT ‘with’ (n=59) and ‘without’ (n=61) ScvO2 groups. Resuscitation was guided by ScvO2 monitoring at 1-hour, 3-hour, and later on six-hourly in the ‘with’ ScvO2 group, and by clinical variables in the ‘without’ ScvO2 group.

Outcome

Primary outcome was all-cause 28-day mortality. Secondary outcomes were time to and proportion of patients achieving therapeutic endpoints (at 6 hours and PICU stay), need for organ supports, new organ dysfunction (at 24 hours and PICU stay), and length of PICU and hospital stay.

Results

The study was stopped after interim analysis due to lower mortality in the intervention group. There was significantly lower all-cause 28-day mortality in EDGT with ScvO2 than without ScvO2 group [37.3% vs. 57.5%, adjusted hazard ratio 0.57, 95%CI 0.33 to 0.97, P=0.04]. Therapeutic endpoints were achieved early in ‘with’ ScvO2 group [mean (SD) 3.6 (1.6) vs. 4.2 (1.6) h, P=0.03]. Organ dysfunction by sequential organ assessment score during PICU stay was lower in ‘with’ ScvO2 group [median (IQR) 5 (2,11) vs. 8 (3,13); P=0.03]. There was no significant difference in other secondary outcomes.

Conclusion

EGDT with intermittent ScvO2 monitoring was associated with reduced mortality and improved organ dysfunction in pediatric septic shock.

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Acknowledgments

We acknowledge the contribution of Mrs. S. Raja Deepa, B.Com, MCA (JIPMER), Puducherry for data handling, review, and editing of the manuscript; Dr. Muthu Chidambaram, MD, DM, Assistant Professor, Depart-ment of Pediatrics, Saveetha Medical College, Chennai, Tamil Nadu, for critical comment on the manuscript; Mr. Rakesh Mohindra (Punjab University, Chandigarh) and Mrs. Thenmozhi M, M.Sc, Ph.D., (Senior Demonstrator, CMC, Vellore) helping with statistical analysis and Mrs. Harpreet Kaur (Punjab University, Chandigarh), and Mrs. Neelima Chadha (Tulsi Das Library, PGIMER, Chandigarh) helping with the medical literature search.

Funding

Funding: JIPMER intramural research grant (JIP/RES/INTRA-DM-M.CH/01/2015-16 and JIP/RES/ INTRA-DM-M.CH/Phase1/Grant 2/01/2016-17) to SM/RR.

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Authors and Affiliations

  1. Division of Pediatric Critical Care, Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India

    Puneet Jain,  Ramachandran Rameshkumar, Ponnarmeni Satheesh & Subramanian Mahadevan

Authors
  1. Puneet Jain
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  2. Ramachandran Rameshkumar
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  3. Ponnarmeni Satheesh
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  4. Subramanian Mahadevan
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Contributions

Contributors: RR: had full access to all the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis; RR, SM: study concept and design; PJ, PS: acquisition, analysis, or interpretation of data; PJ: drafting of the first manuscript; RR: critical revision of the manuscript for important intellectual content; RR, SM: study supervision. All authors approved the final version of the manuscript.

Corresponding author

Correspondence to Ramachandran Rameshkumar.

Ethics declarations

Ethical clearance: Institutional Ethics committee, JIPMER; No.JIP/IEC/2015/16/598, dated June 25, 2015.

Conflict of interests: None stated.

Additional information

Note: Additional material related to this study is available with the online version at https://www.indianpediatrics.net

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Jain, P., Rameshkumar, R., Satheesh, P. et al. Early Goal-Directed Therapy With and Without Intermittent Superior Vena Cava Oxygen Saturation Monitoring in Pediatric Septic Shock: A Randomized Controlled Trial. Indian Pediatr 58, 1124–1130 (2021). https://doi.org/10.1007/s13312-021-2392-2

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Keywords

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